Ohrpunktakupressur zur Behandlung von Chemotherapie-induzierter Neuropathie
9. Juli 2026 aktualisiert von: Jennifer Kawi, The University of Texas Health Science Center, Houston
Die vorgeschlagene randomisierte Kontrollstudie wird die Aurikularpunktakupressur (APA) bei Chemotherapie-induzierter Neuropathie (CIN) bewerten, wobei Punktspezifität und Placebo-Effekte streng berücksichtigt werden, indem Selbstberichtsmaße, psychophysische Maße (QST), endogene Biomarker (Zytokine) und Neuro - Bildgebung zur Untersuchung der Wirksamkeit von APA und der zugrunde liegenden Mechanismen.
Die Ermittler werden eine randomisierte Kontrollstudie mit drei Gruppendesign verwenden: (1) APA-Gruppe, (2) Schein-APA-Kontrolle und (3) Kontrolle der üblichen Pflege. Eine Smartphone-Anwendung für die ökologische Momentanbewertung (EMA) wird verwendet, um die APA-Einhaltung zu überwachen und den momentanen CIN-Schweregrad und die Verwendung von Analgetika zu erfassen.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
Chemotherapie-induzierte Neuropathie (CIN) – Schmerzen, Taubheitsgefühl oder Kribbeln in Händen und Füßen – führt zu anhaltenden Symptomen, die die Empfindung und das Gleichgewicht bei Krebsüberlebenden beeinträchtigen. Bis zu 50 % der Krebsüberlebenden leiden 6 Jahre nach der Behandlung immer noch an CIN. Duloxetin, das einzige von der American Society of Clinical Oncology empfohlene Medikament, erwies sich gegenüber Placebo als überlegen, verbesserte die CIN jedoch nur um 0,73 Punkte (Skala von 0-10). Abgesehen von körperlicher Betätigung wurde keine wirksame Behandlung für CIN etabliert, mit einer Effektgröße von <0,508. Opioide lindern CIN-Schmerzen, aber von einer Langzeitanwendung wird aufgrund des Opioid-Übergebrauchs dringend abgeraten.
Die Forscher schlagen vor, die Ohrpunktakupressur (APA) zu testen, eine innovative und skalierbare Lösung, die aus der Ohrakupunktur entwickelt wurde. APA ist eine nicht-invasive (nadellose) und aktive Behandlung für Schmerzpatienten, während Akupunktur eine invasive (mit Nadeln) und passive Behandlung (durchgeführt von einem zugelassenen Arzt) ist. Bei APA werden kleine Samen von einem erfahrenen Anbieter auf bestimmte Ohrpunkte geklebt und die Patienten drücken dreimal täglich drei Minuten lang auf die Samen, um die Ohrpunkte zu stimulieren, insgesamt neun Minuten pro Tag. APA bietet Schmerzlinderung innerhalb von 1-2 Minuten nach der Ohrstimulation und hält die Schmerzlinderung für einen Monat nach einer 4-wöchigen APA-Intervention aufrecht. APA ist in Taiwan, China und Europa beliebt. Obwohl seine Verwendung in den USA spärlich ist, hat eine begrenzte Anzahl klinischer Studien APA bei der Schmerzbehandlung unterstützt.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
238
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21205
- Johns Hopkins University
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
- The University of Texas Health Science Center at Houston
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Einschlusskriterien:
- Krebspatienten im Alter von ≥ 18 Jahren
- ein Medikament in einer der folgenden Kategorien erhalten haben: auf Platinbasis, Vinca-Alkaloide, Bortezomib, Eribulin und/oder Taxane
- haben ihre Chemotherapie drei Monate oder länger vor der Einschreibung abgeschlossen
- eine CIN aufgrund einer neurotoxischen Chemotherapie gegen Krebs haben oder eine vorbestehende periphere Neuropathie anderer Ätiologie haben, die sich nach der Chemotherapie verschlechtert hat
- eine der durchschnittlichen Intensität von Schmerzen, Taubheitsgefühl oder Kribbeln an den Extremitäten in der vergangenen Woche aufgrund von CIN ≥ 4 auf einer numerischen 11-Punkte-Skala haben.
Ausschlusskriterien:
- Verwendung eines Prüfpräparats zur Schmerzkontrolle gleichzeitig oder innerhalb der letzten 30 Tage
- Verwendung eines implantierbaren Arzneimittelabgabesystems, z. Medtronic SynchroMed®
- vorherige Zöliakie-Plexus-Blockade oder andere neurolytische Schmerzbehandlung
- andere identifizierte Ursachen für schmerzhafte Parästhesien, die vor der Chemotherapie bestanden (z. B. Bestrahlung oder maligne Plexopathie, lumbale oder zervikale Radikulopathie)
- Latexallergie (die Bänder für die APA enthalten Latex).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Aurikuläre Punktakupressur (APA)
Der APA-Arm erhält wöchentliche persönliche Behandlungen und eine selbstgesteuerte Smartphone-Anwendung mit Videos zum Verständnis und zur Verabreichung von APA.
Der APA-Arm erhält eine persönliche Saatplatzierung und eine Schulung für den Teilnehmer oder seine Pflegekraft, um die Samen auf den Ährenpunkten zu platzieren, sowie ein Zoom-Meeting 1 Woche nach dem ersten Besuch, um den Teilnehmer und/oder seine Pflegekraft in Sachen Saatgut zu coachen Platzierung.
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Persönliche Samenplatzierung und eine Schulung für den Teilnehmer oder seinen Betreuer, um die Samen an den Ährenpunkten zu platzieren.
Zoom-Sitzung zur Saatplatzierung und APA-Coaching, die nach dem ersten APA- und Saatplatzierungstraining stattfindet (die erste Schulung findet entweder persönlich statt oder wird durch die Videos der Smartphone-App angeleitet).
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Experimental: Virtuelle Ohrpunktakupressur (vAPA)
Der vAPA-Arm verabreicht APA selbst, indem er die Samen gemäß der Videoanleitung in der selbstgesteuerten Smartphone-Anwendung zum Verständnis und zur Verabreichung von APA platziert.
Der Teilnehmer und/oder eine Pflegekraft befolgen die Videoanweisungen zur Saatplatzierung und erhalten eine Woche nach dem Basisbesuch eine Zoom-Sitzung für APA-Coaching.
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Zoom-Sitzung zur Saatplatzierung und APA-Coaching, die nach dem ersten APA- und Saatplatzierungstraining stattfindet (die erste Schulung findet entweder persönlich statt oder wird durch die Videos der Smartphone-App angeleitet).
Verabreichen Sie APA selbst, indem Sie die Samen gemäß der Videoanleitung in der selbstgeführten Smartphone-Anwendung zum Verständnis und zur Verabreichung von APA platzieren.
Der Teilnehmer und/oder eine Pflegekraft befolgen die Videoanweisungen zur Saatplatzierung.
Andere Namen:
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Aktiver Komparator: Übliche Pflegekontrolle
Der Bereich „Übliche Pflege“ wird mit der üblichen Pflege fortfahren.
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Die Teilnehmer erhalten weiterhin die übliche Betreuung durch einen Onkologen.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Pain Severity as Assessed by the Brief Pain Inventory
Zeitfenster: Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst pain severity.
The scale ranges from 0 (no pain) to 10 (severe pain), a higher score indicates greater pain
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Baseline, 1 month after baseline
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Numbness as Assessed by the Brief Pain Inventory
Zeitfenster: Baseline, 1 month after Baseline
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Brief Pain Inventory (BPI) assesses worst numbness.
The scale ranges from 0 (no numbness) to 10 (severe numbness), a higher score indicates greater numbness.
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Baseline, 1 month after Baseline
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Tingling as Assessed by the Brief Pain Inventory
Zeitfenster: Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst Tingling.
The scale ranges from 0 (no tingling) to 10 (severe tingling), a higher score indicates greater tingling.
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Baseline, 1 month after baseline
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Stiffness as Assessed by the Brief Pain Inventory
Zeitfenster: Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst stiffness.
The scale ranges from 0 (no stiffness) to 10 (severe stiffness), a higher score indicates greater stiffness.
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Baseline, 1 month after baseline
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Grade of Peripheral Motor Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Zeitfenster: Baseline, 1 month after baseline
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Peripheral motor neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
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Baseline, 1 month after baseline
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Grade of Peripheral Sensory Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Zeitfenster: Baseline, 1 month after baseline
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Peripheral sensory neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
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Baseline, 1 month after baseline
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Physical Function as Assessed by The Revised BPI-CIN Pain Interference Subscale
Zeitfenster: Baseline, 1 month after Baseline
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The BPI-CIN Interference subscale will be used to measure physical function caused by CIN.
The seven items evaluate interference with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life.
Each item is rated on a 0-10 numeric scale (0 = does not interfere; 10 = completely interferes).
The overall score is calculated as the mean of the seven items with a total score ranging from 0 to 10 to determine the level of interference, with higher scores indicating greater interference.
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Baseline, 1 month after Baseline
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Functional Ability as Assessed by Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
Zeitfenster: Baseline, 1 month after Baseline
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The ECOG Performance Status Scale describes level of functioning in terms of ability to care for oneself, daily activity, and physical. Score on the ECOG ranges from 0 (fully active and able) to 5 (dead) with higher score indicating lower function: 0 - Fully active, able to carry on all pre-disease performance without restriction
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Baseline, 1 month after Baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Physical Function Subscale
Zeitfenster: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - physical function subscale assesses physical function using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate better physical function.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Fatigue Subscale
Zeitfenster: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - fatigue subscale assesses fatigue using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater fatigue.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Pain Interference Subscale
Zeitfenster: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - pain interference subscale assesses how pain interferes with daily activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater pain interference.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Depression Subscale
Zeitfenster: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - depression subscale assesses depression using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater depression severity.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Anxiety Subscale
Zeitfenster: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - anxiety subscale assesses anxiety using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater anxiety.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Sleep Disturbance Subscale
Zeitfenster: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - sleep disturbance subscale assesses sleep disturbance using 4 items, each scored on a 5-point Likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater sleep disturbance.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Ability to Participate in Social Activities Subscale
Zeitfenster: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - ability to participate in social activities subscale assesses a participant's perceived ability to engage in usual social roles and activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate better and higher functioning social participation.
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Baseline, 1 month after baseline
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Upper Limb Function as Assessed by the Quick Dash Index
Zeitfenster: Baseline, 1 month after baseline
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The QuickDASH Index assesses upper limb disability and symptoms.
It evaluates limitations in daily activities (e.g., opening jars, performing housework), as well as pain, tingling, and sleep disturbances.
The total score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating greater disability.
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Baseline, 1 month after baseline
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Symptoms Severity as Assessed by the MD Anderson Symptom Severity Inventory
Zeitfenster: Baseline, 1 month after Baseline
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The MD Anderson Sympton Severity Inventory assesses severity of 13 common symptoms experienced by patients with cancer.
Each item is rated on a 0-10 numeric scale (0 = not present; 10 = as bad as you can imagine).
The overall symptom severity score is calculated as the mean of the 13 items with a range of 0 to 10, higher scores indicating greater symptom severity.
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Baseline, 1 month after Baseline
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Pain Self Efficacy as Assessed by Pain Self-Efficacy Questionnaire (PSEQ)
Zeitfenster: Baseline, 1 month after Baseline
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Pain self-efficacy is assessed using the Pain Self-Efficacy Questionnaire (PSEQ).
This 10-item instrument measures a participant's confidence in performing daily activities, social life and function despite pain.
Each item is rated on a 0-6 scale (0 = Not at all confident; 6 = Completely confident) and total score ranges from 0 to 60, with higher scores indicating greater self-efficacy and greater confidence in coping.
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Baseline, 1 month after Baseline
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Psychological Impact of Pain as Assessed by the Pain Catastrophizing Score
Zeitfenster: Baseline, 1 month after Baseline
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The Pain Catastrophizing Scale (PCS) assesses components of catastrophizing: rumination, magnification, and helplessness.
The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
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Baseline, 1 month after Baseline
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Number of Chronic Overlapping Pain Conditions as Assessed by the Chronic Overlapping Pain Conditions (COPC)
Zeitfenster: Baseline, 1 month after Baseline
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Chronic Overlapping Pain Conditions (COPC) are assessed using the Chronic Overlapping Pain Conditions Screener (COPCS).
This instrument identifies the presence of up to 10 common chronic pain conditions.
The COPC total score is calculated as the number of positively identified conditions (answered "Yes"), with higher scores indicating greater pain impact, central sensitization, and severity.
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Baseline, 1 month after Baseline
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Charlson Comorbidity Index
Zeitfenster: Baseline
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The Charlson Comorbidity index assesses a participant's comorbidity burden and predicted risk of mortality.
The total score ranges from 0 to 37. A higher score indicates greater comorbidity burden and higher risk of mortality.
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Baseline
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Pain Impact as Assessed by Pain, Enjoyment and General Activity (PEG) Scale
Zeitfenster: Baseline, 1 month after baseline
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Pain, Enjoyment and General Activity (PEG) is a three-item questionnaire that assesses pain intensity and its impact patient's daily life.
Each item is rated on a 0-10 scale.
The PEG score is calculated as the mean of three items, resulting in score range of 0 to 10, with a higher scores indicating greater pain severity and functional interference.
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Baseline, 1 month after baseline
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Number of Participants Reporting Opioid Use
Zeitfenster: Baseline, Day 28
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Baseline, Day 28
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Opioid Use Per Day as Measured by the Morphine Milligram Equivalents (MME) Per Day
Zeitfenster: Baseline, Day 28
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Opioid use will be collected via EMA diary using a questionnaire.
Milligram Morphine Equivalent (MME) will be determined by using an equivalency factor to calculate a dose of morphine equivalent to the ordered opioid.
Daily morphine equivalent dosing is sum of the MME of all opioids a patient is likely to take within 24 hours, and will be calculated to MME for analysis.
Baseline was defined as the first day of opioid use recorded in the EMA diary.
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Baseline, Day 28
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Trapezius
Zeitfenster: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful."
The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Thumb
Zeitfenster: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful."
The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Mechanical Temporal Summation (MTS)
Zeitfenster: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess MTS, a single pinprick stimulus (e.g., via a weighted pinprick stimulator or Neuropen) is applied, followed by a series of 10 rapid, identical stimuli at the same location, usually at a rate of 1/second, to measure the change in pain sensation.
Participants rate their pain after the stimuli using a Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 = no pain and 10 = worst pain imaginable.
A higher score means greater pain sensitivity and increased temporal summation.
MTS is calculated as the increase in pain intensity rating (Δ change score) between the first stimulus and the end of the series.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
Zeitfenster: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
CPM was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 4 degrees Celsius for 20 seconds.
[ [To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).]
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Baseline, 1 month after Baseline
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Functional Connectivity Changes in Salience Network - Basal Ganglia Network (SAL-BGN) as Assessed by fMRI Neuroimaging
Zeitfenster: Baseline
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Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline).
Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions.
Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.
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Baseline
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Functional Connectivity Changes in Language Network - Basal Ganglia Network (LAN-BGN) as Assessed by fMRI Neuroimaging
Zeitfenster: Baseline, 1 month after Baseline
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Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline).
Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions.
Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.
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Baseline, 1 month after Baseline
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The Grooved Pegboard Test-Dominant Hand
Zeitfenster: Baseline, 1 month after baseline
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The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination.
Participants are asked to place 25 pegs into slots as quickly as possible.
The total time to complete the task is recorded in seconds with dominant hand.
Higher times indicate slower performance and reduced dexterity
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Baseline, 1 month after baseline
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The Grooved Pegboard Test-Non Dominant Hand
Zeitfenster: Baseline, 1 month after Baseline
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The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination.
Participants are asked to place 25 pegs into slots as quickly as possible.
The total time to complete the task is recorded in seconds with non-dominant hand.
Higher times indicate slower performance and reduced dexterity
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Baseline, 1 month after Baseline
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Interleukin-1 Alpha Level (From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-1 Beta Level (From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-2 Level (From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-4 Level (From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-6 Level (From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-8 Level (From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-10 Level (From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-12 Level (p40) (From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-12 Level (p70)-(From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-13 Level (From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-17 Level (From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interferon-gamma Level (From Plasma)
Zeitfenster: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Tumor Necrosis Factor-alpha Level (From Plasma)
Zeitfenster: Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline
|
|
Tumor Necrosis Factor-alpha Level (From Plasma)
Zeitfenster: 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
1 month after baseline
|
|
Transforming Growth Factor-beta Level 1(From Plasma)
Zeitfenster: Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline
|
|
Transforming Growth Factor-beta Level 1 (From Plasma)
Zeitfenster: 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
1 month after baseline
|
|
Calcitonin Gene-related Peptide Level(From Plasma)
Zeitfenster: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
Monocyte Chemoattractant Protein-1 Level (From Plasma)
Zeitfenster: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
Eotaxin Level (From Plasma)
Zeitfenster: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
C-reactive Protein Level (From Plasma)
Zeitfenster: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Nada Lukkahatai, PHD, MSN, RN, Johns Hopkins University
- Hauptermittler: Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN, The University of Texas Health Science Center, Houston
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
8. Juli 2021
Primärer Abschluss (Tatsächlich)
30. Mai 2025
Studienabschluss (Tatsächlich)
19. März 2026
Studienanmeldedaten
Zuerst eingereicht
3. Juni 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. Juni 2021
Zuerst gepostet (Tatsächlich)
9. Juni 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
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Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HSC-SN-21-1085
- 1R01CA245054-01A1 (US NIH Stipendium/Vertrag)
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