Potential Role of Acupuncture Treatment in Neuronal and Network Dysfunction in Patients With Vascular Cognitive Impairment
Vascular cognitive impairment (VCI) is a broad dimensional term, ranging from mild cognitive impairment without incapacity on activity of daily living to vascular dementia (VaD), referred to as significant cognitive impairment and decline in function status.
In this three-year project, we aim to evaluate the effects of biochemical data, early clinical variables, neuroimaging results, and intervention of acupuncture treatment on vascular event related cognitive impairment in crossectional analysis and longitudinal follow-up.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Stroke is a common cerebrovascular disease of the central nervous system leading to serious medical complication. It results in a high mortality rate and increased disability rate. Stroke survivors may have long-lasting consequences, including motor dysfunction, sensibility dysfunction, and cognitive impairment]. Cognition is a key component of rehabilitation and recovery; therefore it is associated with poor engagement in rehabilitee and outcomes including increased mortality. As vascular dementia (VaD) is considered the second-most-common type of dementing illness, accounting for a significant proportion of total dementia case, vascular cognitive impairment (VCI) is a broader dimensional term, ranging from mild cognitive impairment without incapacity on activity of daily living to VaD, referred to as significant cognitive impairment and decline in function status.
Acupuncture is an ancient Chinese medical technique in which fine, stainless steel needles are inserted into certain anatomical locations of the body surface to elicit neurohormonal responses of the body system via nerve stimulation. Acupuncture are reported to be probably effective in improving cognitive function in vascular dementia animal models via multiple mechanisms such as anti-apoptosis, antioxidative stress reaction, and metabolism enhancing of glucose and oxygen.
Motor features may not parallel to the cognitive changes, it will serve as the disease progression marker. Unified Parkinson's Disease Rating Scale (UPDRS)-part III scores and NIH Stroke Scale (NIHSS) will be used.
- At Kaohsiung Chang Gung Memorial Hospital, all the patients (n=80) will be included and receive a Standardized Acupuncture intervention; 40 will be treated with regular medication; 40 will be treated with acupuncture and regular medication.
- For acupressure program, all participants are treated in supine position, and a certified TCM physician applied firm pressure (3 to 5 kg of pressure) with fingertips in a circular motion at a speed of 2 circles per second for a duration of one minute per acupoint. The complete process lasts for 8 minutes.
Cognitive function, Motor function, Mood and Sleep will be evaluated at baseline and follow-up period of time at 3 month, 6 month, and 12 month.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: YaTing Chang, MD,PhD
- Telefonnummer: 077317123
- E-Mail: emily0606@cgmh.org.tw
Studienorte
-
-
-
Kaohsiung, Taiwan, 83301
- Rekrutierung
- Kaohsiung Chang Gung Memorial Hospital
-
Kontakt:
- YaTing Chang
- Telefonnummer: 077317123
- E-Mail: emily0606@cgmh.org.tw
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
1. Fulfill the diagnostic criteria of vascular cognitive impairment
Exclusion Criteria:
- Systemic inflammatory disease with on-going treatment
- Severe psychiatric disease, such as major depressive disorder or schizophrenia
- Severe traumatic brain injury
- Unable to tolerate exam of brain MRI
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Schein-Komparator: regular medication treatment
|
acupuncture treatment on selected acupoint
|
|
Experimental: acupuncture and regular medication treatment
|
acupuncture treatment on selected acupoint
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline sleep quality at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
Analogous variables were extracted from actigraphy.
The sleep variables collected were sleep start time, sleep end time, sleep duration, sleep efficiency, and wake after sleep onset time, and the activity variables collected were heart rate activity score,activity amount, and activity intensity
|
3 months, 6 months, 12 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
Cognitive Abilities Screening Instrument (CASI).
In addition to general cognitive performance, CASI was used to evaluate specific domains, including short-term memory, attention and concentration, abstraction, visual construction, language, and list-generating fluency.
|
3 months, 6 months, 12 months
|
|
Change from baseline motor function (UPDRS) at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
Unified Parkinson's Disease Rating Scale (UPDRS)-part III scores for parkinsonian features.
|
3 months, 6 months, 12 months
|
|
Change from baseline motor function (NIHSS) at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
NIH Stroke Scale (NIHSS) score 0-24.
|
3 months, 6 months, 12 months
|
|
Change from baseline continuous motor function at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
Physical activity was measured using accelerometers.
|
3 months, 6 months, 12 months
|
|
Change from baseline memory performances at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
Verbal memory were evaluated by using Chinese Version Verbal Learning Test (CVVLT).Visual-spatial abilities.
|
3 months, 6 months, 12 months
|
|
Change from baseline executive performances at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
Attention and executive function was evaluated by Trail Making Test B.
|
3 months, 6 months, 12 months
|
|
Change from baseline executive performances (Stroop interference test) at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
Attention and executive function was evaluated by Stroop interference test.
|
3 months, 6 months, 12 months
|
|
Change from baseline executive performances (calculation) at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
As the calculation ability depends on executive function, calculation ability was evaluated to reflect part of executive function.
|
3 months, 6 months, 12 months
|
|
Change from baseline abstract thinking at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
Abstract reasoning was evaluated by using similarities (conceptualization) in frontal assessment battery-Similarities.
|
3 months, 6 months, 12 months
|
|
Change from baseline language performances at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
Boston Naming Test were used to evaluate language ability in naming.
|
3 months, 6 months, 12 months
|
|
Change from baseline fluency performances at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
Semantic category fluency.
|
3 months, 6 months, 12 months
|
|
Change from baseline neuropsychiatric symptoms at 3 months, 6 months, 12 months
Zeitfenster: 3 months, 6 months, 12 months
|
The neuropsychiatric symptoms of the participants were measured using the Neuropsychiatric Inventory.
|
3 months, 6 months, 12 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: YaTing Chang, MD,PhD, Chang Gung Memorial Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 201802103A3
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Vaskuläre kognitive Beeinträchtigung
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Population Health Research Institute und andere MitarbeiterAktiv, nicht rekrutierendChirurgie (Herz) | Chirurgie (Major Vascular)Kanada, Vereinigtes Königreich
-
Assiut UniversityNoch keine RekrutierungGAVE - Gastric Antral Vascular Ectasie
-
H. Lee Moffitt Cancer Center and Research InstituteColumbia University; University Hospitals Cleveland Medical Center; Geisinger... und andere MitarbeiterSuspendiertBlutung | GAVE - Gastric Antral Vascular Ectasie | Blutender MagenVereinigte Staaten
-
Tianjin Huanhu HospitalAbgeschlossenBildauswertung | Endovaskuläre Thrombektomie | Fluid-attenuated Inversion Recovery Sequence Vascular Hyperintensity-Diffusion-Weighted Imaging Mismatch (FVH-DWI Mismatch)China