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Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke

16. november 2022 opdateret af: Raymond KY Tong, Chinese University of Hong Kong
High definition tDCS will be conducted to both stroke and healthy subjects on primary motor cortex area to explore the motor excitability changes before and after stimulation. In next stage, a randomized control trial with 20-session training will be conducted to evaluate the effectiveness of transient modulation of cortical excitability through multisite HD-tDCS with EMG driven robot hand training, a sham stimulation with EMG-driven robot hand training will be applied as control group.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • Rekruttering
        • Department of Biomedical Engineering, The Chinese University of Hong Kong
        • Kontakt:
          • Raymond Tong, PhD
          • Telefonnummer: +852 3943 8454

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
  2. Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), and Action Research Arm Test (ARAT));
  3. Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection

Exclusion Criteria:

  1. Severe hand spasticity, open hand wound or hand deformity;
  2. Visual field deficits;
  3. Aphasia, neglect, and apraxia;
  4. History of alcohol, drug abuse or epilepsy;
  5. Bilateral infracts;
  6. Uncontrolled medical problems;
  7. Serious cognitive deficits [Mini-Mental State Examination (MMSE) < 21];
  8. Major depression
  9. Metal implants inside body
  10. MRI, TMS and tDCS contraindications

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Anode HD-tDCS
The center anode is fixed on the ipsilesional primary motor cortex and the 4 surrounding cathode electrodes will be placed about 6 cm to the center.
Enhed: HD-tDCS
Different stimulation protocols will be applied to the primary motor cortex of stroke patients. After 20-minute stimulation, EMG-driven robot hand training will be conducted.
Eksperimentel: Cathode HD-tDCS
The center cathode is fixed on the contralesional primary motor cortex and the 4 surrounding anode electrodes will be placed about 6 cm to the center.
Enhed: HD-tDCS
Different stimulation protocols will be applied to the primary motor cortex of stroke patients. After 20-minute stimulation, EMG-driven robot hand training will be conducted.
Placebo komparator: Sham HD-tDCS
The center anode is fixed on the ipsilesional primary motor cortex and the 4 surrounding cathode electrodes will be placed about 6 cm to the center.
Enhed: HD-tDCS
Different stimulation protocols will be applied to the primary motor cortex of stroke patients. After 20-minute stimulation, EMG-driven robot hand training will be conducted.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Electroencephalography (EEG) and Electromyography (EMG)
Tidsramme: Before intervention, During intervention, After intervention, 6-month after intervention
It is used to investigate the changes in corticomuscular coherence for studying connectivity between the brainwave using EEG and the affected hand muscles using EMG. In addition, EMG will be used to detect muscle activation change and muscle co-contraction pattern alteration.
Before intervention, During intervention, After intervention, 6-month after intervention
Action Research Arm Test (ARAT)
Tidsramme: Before intervention, After intervention, 6-month after intervention
The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning
Before intervention, After intervention, 6-month after intervention
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Tidsramme: Before intervention, After intervention, 6-month after intervention
It is used to evaluate and measure upper-limb recovery in post-stroke hemiplegic patients, and items are scored on a 3-point ordinal scale
Before intervention, After intervention, 6-month after intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Magnetic Resonance Imaging (MRI)
Tidsramme: Before intervention, After intervention, 6-month after intervention
It is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations
Before intervention, After intervention, 6-month after intervention
Transcranial Magnetic Stimulation (TMS)
Tidsramme: Before intervention
It is used to measure the changes in interhemispheric imbalance and corticospinal excitability
Before intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese University of Hong Kong

Efterforskere

  • Ledende efterforsker: Raymond Kai-yu Tong, PhD, Department of Biomedical Engineering, CUHK

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. juni 2016

Primær færdiggørelse (Forventet)

31. december 2022

Studieafslutning (Forventet)

31. december 2022

Datoer for studieregistrering

Først indsendt

14. september 2016

Først indsendt, der opfyldte QC-kriterier

7. november 2016

Først opslået (Skøn)

9. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. november 2022

Sidst verificeret

1. november 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2015.691-T

Plan for individuelle deltagerdata (IPD)

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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