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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Kaohsiung, Tajwan, 83301
- Rekrutacyjny
- Kaohsiung Chang Gung Memorial Hospital
-
Kontakt:
- YaTing Chang
- Numer telefonu: 077317123
- E-mail: emily0606@cgmh.org.tw
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Pozorny komparator: regular medication treatment
|
acupuncture treatment on selected acupoint
|
|
Eksperymentalny: acupuncture and regular medication treatment
|
acupuncture treatment on selected acupoint
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline sleep quality at 3 months, 6 months, 12 months
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 3 months, 6 months, 12 months
|
The neuropsychiatric symptoms of the participants were measured using the Neuropsychiatric Inventory.
|
3 months, 6 months, 12 months
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: YaTing Chang, MD,PhD, Chang Gung Memorial Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 201802103A3
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .