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Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke (DAS)

24. juni 2021 oppdatert av: Taewon Kim, Incheon St.Mary's Hospital

Investigation of the Effects of Noninvasive Neuromodulation in Patients With Acute Ischemic Infarction

Non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe in participants with cerebral infarction. However, few studies have been done in participants with acute cerebral infarction. In this study, the investigators want to see the effect of tDCS in acute cerebral infarction. the investigators perform tDCS in participants with acute ischemic stroke within 48 hours after stroke onset and the investigators measure motor weakness and function at early phase as well as at 3 months.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Cerebral infarction is a major cause of death, a disease that is socially and nationally burdensome, leaving disabilities and dementia behind.

In participants with cerebral infarction, non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe. However, few studies have been done in participants with acute cerebral infarction, and previous studies in participants with acute cerebral infarction have not verified the effect in mild cerebral infarction, and previous studies in acute cerebral infarction mainly stimulate lesions to anode. So in this study, the investigators want to see the effect of stimulating tDCS to both hemispheres in acute cerebral infarction against this backdrop.

Study Objective: To see if tDCS is effective in improving motor paralysis in participants with acute cerebral infarction.

Expected effectiveness: stability of tDCS has already been demonstrated in many studies. Since tDCS itself is a non-invasive treatment, if the efficacy of the tDCS prove to be effective in patients with acute cerebral infarction, it can be widely implemented without significant risk to many patients.

Intervention : In this randomized controlled trial, the investigators perform tDCS in patients with acute ischemic stroke within 48 hours after stroke onset with sham control.

Outcome : the investigators measure motor weakness and function at early phase as well as at 3 months.

Studietype

Intervensjonell

Registrering (Forventet)

172

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Korea, Republikken
      • Incheon, Korea, Republikken, 21431
        • Rekruttering
        • The Catholic University of Korea, Incheon St. Mary's 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

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • ischemic stroke patients within 2 days stroke onset
  • 18-85 of age
  • corticospinal tract involvement stroke (primary motor cortex, corona radiata, internal capsule, midbrain crus cerebri, basis pontis, anterior medulla)

Exclusion Criteria:

  • pre-stroke disability (defined as modified Rankin Scale (mRS) >=2)
  • Intravenous r-tPA thrombolysis or EVT (endovascular thrombectomy)
  • history of epilepsy
  • advanced systemic disease or coexisting neurological/psychiatric disease
  • severe contact dermatitis or skin lesions interfering with the applying the electrode of tDCS

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: tDCS group

tDCS stimulation

  • affected side :

    1. primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system)
    2. 2mA anode (+) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days)

  • contralateral unaffected side

    1. primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system)
    2. 2mA cathode (-) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days)
Enhet: Transcranial direct current stimulation
Transcranial direct current stimulation on motor cortex
Sham-komparator: Sham group

. Sham stimulation

1) the current ramps up to 2mA and slowly decreased over 30 s to ensure the typical initial tingling sensation
Enhet: Transcranial direct current stimulation
Transcranial direct current stimulation on motor cortex

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fugl-Meyer (FM) motor scale, short form
Tidsramme: at admission
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
at admission
Fugl-Meyer (FM) motor scale, short form
Tidsramme: at 7 days
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
at 7 days
Fugl-Meyer (FM) motor scale, short form
Tidsramme: at 3 month
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
at 3 month
NIHSS (National Institutes of Health Stroke Scale)
Tidsramme: at admission
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
at admission
NIHSS (National Institutes of Health Stroke Scale)
Tidsramme: at 7 days
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
at 7 days
NIHSS (National Institutes of Health Stroke Scale)
Tidsramme: at 3 month
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
at 3 month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
modified Rankin scale
Tidsramme: at 3 month
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials.
at 3 month

Samarbeidspartnere og etterforskere

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

Sponsor

Incheon St.Mary's Hospital

Samarbeidspartnere

The Catholic University of Korea

Etterforskere

  • Hovedetterforsker: Taewon Kim, MD, PhD, Incheon St.Mary's 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)

16. april 2020

Primær fullføring (Forventet)

31. august 2022

Studiet fullført (Forventet)

31. desember 2022

Datoer for studieregistrering

Først innsendt

15. juni 2021

Først innsendt som oppfylte QC-kriteriene

20. juni 2021

Først lagt ut (Faktiske)

24. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juni 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juni 2021

Sist bekreftet

1. juni 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • OC19DESI0124

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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