Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Hemiparesis
Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / 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.
|
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.
|
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.
|
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
|
|
Sham Comparator: 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.
|
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in Fugl Meyer Assessment
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in Action Research Arm Test
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 11CRP7220009
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Kliniska prövningar på Neuroconn Eldith stimulator by Magstim
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Institut National de la Santé Et de la Recherche...Assistance Publique - Hôpitaux de ParisAvslutadExcitabilitet av diafragma primärmotorisk cortexFrankrike
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Centre d'Investigation Clinique et Technologique...Adep AssistanceAvslutad