- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03124147
Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Hemiparesis
Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Active Comparator: 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.
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Fugl Meyer Assessment
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Action Research Arm Test
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11CRP7220009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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