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Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Hemiparesis

21. april 2017 opdateret af: Lumy Sawaki

Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis

This study will compare the effectiveness of different polarities of transcranial direct current stimulation paired with intensive motor training in recovery of upper extremity function in individuals with severe post-stroke hemiparesis. The hypothesis is that more severely impaired individuals will derive greater benefit from anodal stimulation of the ipsilesional hemisphere or cathodal stimulation of the contralesional hemisphere than dual stimulation (anodal applied to the ipsilesional hemisphere and cathodal applied to the contralesional hemisphere.)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study has 2 aims: 1) determine which transcranial direct current stimulation (tDCS) electrode configuration is most effective in combination with motor training to promote motor recovery from severe post-stroke hemiparesis; and 2) begin to clarify the extent to which baseline transcranial magnetic stimulation (TMS) measures predict response to tDCS, as well as the effects of tDCS paired with motor training on TMS measures of motor cortical organization.

To accomplish these aims, the investigators will recruit 36 human subjects with severe post-stroke hemiparesis and assign each subject to 1 of 4 tDCS conditions (anodal excitatory ipsilesional; cathodal inhibitory contralesional; a combination of anodal excitatory ipsilesional during cathodal inhibitory contralesional; or sham). Each subject will undergo a 20-minute stimulation session once a day for 10 days over a 2-week period. Each session will be followed by 3 hours of intensive, task-oriented upper extremity motor training.

Outcome measures for this study include TMS motor cortical maps and standardized tests of motor performance. The investigators hypothesize that all groups will show improvement in all measures; however, both the anodal excitatory ipsilesional group and the cathodal inhibitory contralesional group will show significantly greater improvement compared with the other 2 groups. The investigators will also find evidence clarifying whether the presence or absence of motor-evoked potentials (MEPs) has predictive value regarding which tDCS configuration would be most effective for a particular subject.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

38

Fase

  • Ikke anvendelig

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:

  • Chronic stroke patients
  • Single stroke
  • Chronic (more than 12 months after from stroke)
  • At least 18 years old, but there is no upper age range for this project.
  • Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.

Exclusion Criteria:

  • History of head injury with loss of consciousness, seizure, severe alcohol or drug abuse, psychiatric illness
  • Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
  • Cognitive deficit severe enough to preclude informed consent
  • Positive pregnancy test or being of childbearing age and not using appropriate contraception
  • Participants with history of untreated depression.

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: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Anodal tDCS with motor training
20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
Enhed: Neuroconn Eldith stimulator by Magstim
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
Aktiv komparator: Cathodal tDCS with motor training
20 minutes of cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
Enhed: Neuroconn Eldith stimulator by Magstim
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
Aktiv komparator: Dual tDCS with motor training
20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere and cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
Enhed: Neuroconn Eldith stimulator by Magstim
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
Sham-komparator: Sham tDCS with motor training
20 minutes of sham transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
Enhed: Neuroconn Eldith stimulator by Magstim
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in Fugl Meyer Assessment
Tidsramme: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline

Sekundære resultatmål

Resultatmål
Tidsramme
Change in Action Research Arm Test
Tidsramme: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
Change in Stroke Impact Scale
Tidsramme: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline

Samarbejdspartnere og efterforskere

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

Sponsor

Lumy Sawaki

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)

1. august 2011

Primær færdiggørelse (Faktiske)

1. oktober 2013

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

18. april 2017

Først indsendt, der opfyldte QC-kriterier

18. april 2017

Først opslået (Faktiske)

21. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11CRP7220009

Plan for individuelle deltagerdata (IPD)

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