Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Potential Role of Acupuncture Treatment in Neuronal and Network Dysfunction in Patients With Vascular Cognitive Impairment

1 oktober 2019 bijgewerkt door: Chang Gung Memorial Hospital

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

  1. 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.
  2. 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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Werving
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

1. Fulfill the diagnostic criteria of vascular cognitive impairment

Exclusion Criteria:

  1. Systemic inflammatory disease with on-going treatment
  2. Severe psychiatric disease, such as major depressive disorder or schizophrenia
  3. Severe traumatic brain injury
  4. Unable to tolerate exam of brain MRI

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Sham-vergelijker: regular medication treatment
Apparaat: Acupuncture
acupuncture treatment on selected acupoint
Experimenteel: acupuncture and regular medication treatment
Apparaat: Acupuncture
acupuncture treatment on selected acupoint

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline sleep quality at 3 months, 6 months, 12 months
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 3 months, 6 months, 12 months
The neuropsychiatric symptoms of the participants were measured using the Neuropsychiatric Inventory.
3 months, 6 months, 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chang Gung Memorial Hospital

Onderzoekers

  • Hoofdonderzoeker: YaTing Chang, MD,PhD, Chang Gung Memorial Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 september 2019

Primaire voltooiing (Verwacht)

1 september 2020

Studie voltooiing (Verwacht)

1 juli 2022

Studieregistratiedata

Eerst ingediend

18 augustus 2019

Eerst ingediend dat voldeed aan de QC-criteria

11 september 2019

Eerst geplaatst (Werkelijk)

12 september 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 oktober 2019

Laatste update ingediend die voldeed aan QC-criteria

1 oktober 2019

Laatst geverifieerd

1 augustus 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 201802103A3

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren