Effects and Mechanisms of Temporal Interference Stimulation (TIS) on Neuropathic Pain (TIS)
29. Juli 2026 aktualisiert von: Second Affiliated Hospital, School of Medicine, Zhejiang University
This study employs temporal interference stimulation (tTIS) to investigate the analgesic effects of tTIS on neuropathic pain and monitor changes in neural plasticity, and explore the dynamic relationship between analgesic efficacy and neural plasticity, thereby providing new strategies for the treatment of neuropathic pain.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
60
Phase
- Unzutreffend
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
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- IASP diagnosis of peripheral neuropathic pain;
- At least one month after the onset of pain;
- At least moderate pain intensity (≥ 3 assessed by VAS or NRS);
- 18 years or older;
- Stable medical treatment from 2 weeks before allocation to the end of the trial;
- Willing to receive TIS treatment and capable of fulfilling clinical assessments.
Exclusion Criteria:
- Contradictions to TIS treatment, such as metal implants or seizure;
- Serious psychiatric disorder (Hamilton Depression Rating Scale score ≥ 35 or Hamilton Anxiety Rating Scale score ≥ 29);
- Aphasia or cognitive disorders (Mini mental state examination ≤ 24);
- Severe clinical disorders caused by tumor or other conditions;
- Severe cardiopulmonary dysfunction or extreme weakness;
- History of substance abuse (alcohol, drugs).
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: tTIS group
Following enrollment, patients underwent TIS treatment administered twice daily over five consecutive days, for a total of ten sessions.
The stimulation was targeted at the periaqueductal gray (PAG) region contralateral to the side of pain.
Assessments were conducted before treatment (T0) and immediately after the treatment course (T1), evaluating pain perception, emotional changes, and quality of life.
Additionally, local and whole-brain mechanisms were examined using TIS-EEG and fMRI.
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tTIS was applied to the PAG contralateral to the pain side for a duration of 20 minutes, comprising a 30-second ramp-up phase and a 30-second ramp-down phase.
Andere Namen:
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Schein-Komparator: Sham group
The sham group followed the same procedure as the TIS group.
However, the electrical current was only delivered in a 30-second ramp-up at the beginning and a 30-second ramp-down at the end of each session to replicate the initial peripheral sensation without providing sustained therapeutic stimulation.
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tTIS was applied to the PAG contralateral to the pain side for a duration of 20 minutes, comprising a 30-second ramp-up phase and a 30-second ramp-down phase.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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visual analogue scale(VAS)
Zeitfenster: Day1(Baseline), day 5 after intervention
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It typically consists of a 10-centimeter straight line, with two endpoints representing extreme states of the measured experience.
For example, when assessing pain, one end is labeled "0 (no pain at all)" and the other end "10 (worst pain imaginable, unbearable)".
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Day1(Baseline), day 5 after intervention
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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short-form McGill Pain Questionnaire (SF-MPQ)
Zeitfenster: Day1(Baseline), day 5 after intervention
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The Pain Rating Index of the Short-Form McGill Pain Questionnaire consists of 15 pain descriptors, including 11 sensory descriptors and 4 affective descriptors.
Each item is rated from 0 (none) to 3 (severe).
Item scores are summed to produce a total score ranging from 0 to 45, with higher scores indicating greater pain severity.
The outcome measure is the change in the total Pain Rating Index score from baseline to Day 5 after intervention.
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Day1(Baseline), day 5 after intervention
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Brief Pain Inventory (BPI)
Zeitfenster: Day1(Baseline), day 5 after intervention
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0 = "does not interfere" to 10 = "interferes completely" based on the past 24 hours.
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Day1(Baseline), day 5 after intervention
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The Patient Global Impression of Change (PGIC)
Zeitfenster: Day1(Baseline), day 5 after intervention
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Single-item structure: It consists of a single question that asks patients to rate how much their condition has changed since a specified baseline.2.7-point response scale: Responses range from "very much improved" (score 1) to "very much worse" (score 7), with intermediate options including "much improved," "minimally improved," "no change," "minimally worse," and "much worse."
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Day1(Baseline), day 5 after intervention
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17-items of Hamilton Depression Rating Scale (HAMD)
Zeitfenster: Day1(Baseline), day 5 after intervention
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The HAMD-17 provides a comprehensive, multi-dimensional snapshot of depression severity, heavily emphasizing sleep, physical (somatic), and anxiety symptoms alongside core mood symptoms
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Day1(Baseline), day 5 after intervention
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The Beck Depression Inventory-II (BDI-II)
Zeitfenster: Day1(Baseline), day 5 after intervention
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BDI-II is a widely used self-report questionnaire designed to assess the severity of depressive symptoms in adults and adolescents.It consists of 21 items, each describing a specific depressive symptom (e.g., sadness, loss of interest, guilt, fatigue, sleep disturbances, appetite changes).
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Day1(Baseline), day 5 after intervention
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TIS-EEG: Mean Change From Baseline in Resting-State Posterior Alpha-Band Relative Power at Day 5
Zeitfenster: Day 1 before the first intervention and Day 5 within 30 minutes after completion of the final intervention
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A 5-minute eyes-closed resting-state electroencephalography recording will be obtained before the first intervention and after the final intervention.
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Day 1 before the first intervention and Day 5 within 30 minutes after completion of the final intervention
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Mean Within-Session Change in Alpha-Band Relative Power During Transcranial Temporal Interference Stimulation on Day 5
Zeitfenster: During the 20-minute transcranial temporal interference stimulation session on Day 5
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Electroencephalography will be continuously recorded during the 20-minute transcranial temporal interference stimulation session.
After removal of stimulation-related and physiological artifacts using a prespecified preprocessing procedure, alpha-band relative power will be calculated within the 8-13 Hz frequency range and averaged across all included electroencephalography electrodes.
Relative alpha power will be calculated as alpha-band power divided by total power within the 1-45 Hz frequency range and multiplied by 100.
The within-session change will be calculated as the mean relative alpha power during the final 5 minutes of stimulation minus the mean relative alpha power during the first 5 minutes of stimulation and reported in percentage points.
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During the 20-minute transcranial temporal interference stimulation session on Day 5
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
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 (Geschätzt)
1. August 2026
Primärer Abschluss (Geschätzt)
31. Dezember 2027
Studienabschluss (Geschätzt)
31. Januar 2028
Studienanmeldedaten
Zuerst eingereicht
9. Februar 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Juli 2026
Zuerst gepostet (Tatsächlich)
30. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
30. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Juli 2026
Zuletzt verifiziert
1. Januar 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025-1132
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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