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

1. oktober 2019 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Forventet)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Rekruttering
        • Kaohsiung Chang Gung Memorial Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Sham-komparator: regular medication treatment
Enhet: Acupuncture
acupuncture treatment on selected acupoint
Eksperimentell: acupuncture and regular medication treatment
Enhet: Acupuncture
acupuncture treatment on selected acupoint

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline sleep quality at 3 months, 6 months, 12 months
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months, 6 months, 12 months
The neuropsychiatric symptoms of the participants were measured using the Neuropsychiatric Inventory.
3 months, 6 months, 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chang Gung Memorial Hospital

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2019

Primær fullføring (Forventet)

1. september 2020

Studiet fullført (Forventet)

1. juli 2022

Datoer for studieregistrering

Først innsendt

18. august 2019

Først innsendt som oppfylte QC-kriteriene

11. september 2019

Først lagt ut (Faktiske)

12. september 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. oktober 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 201802103A3

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