A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training
NCT ID: NCT02132520
Last Updated: 2019-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2014-03-31
2017-06-30
Brief Summary
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The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects receiving supplementary rTMS and BCI training will show greater functional improvements in hand motor ability over time as well as recovery of normal motor connectivity patterns.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Subjects receiving standard-of-care physical therapy only.
No interventions assigned to this group
Sham rTMS + Real BCI Training
Subjects will receive sham rTMS followed by real BCI training.
rTMS
Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training
BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
Real rTMS + Real BCI Training
Subjects will receive real rTMS followed by real BCI training.
rTMS
Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training
BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
Interventions
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rTMS
Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training
BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
Eligibility Criteria
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Inclusion Criteria
* Cortical or subcortical stroke with isolated unilateral motor paresis
* At least 3 months but no greater than 12 months post stroke and in stable conditions as judged by patient's physician
* Impaired hand function compared to nonparetic side but at least 10 degrees of active finger extension
* Able to ambulate at least 50 feet with minimal stand-by assistance
* Upper Extremity Fugl Meyer (Fugl-Meyer et al., 1975) score of greater than or equal to 20 out of 66
* Beck Depression Inventory (Beck et al., 1961) less than or equal to 19 out of 63
* Mini-mental State Examination score (Folstein et al., 1975) greater than or equal to 24 out of 30
* Must have an ipsilesional motor-evoked potential (MEP) in response to TMS
* Must be stable outpatients currently undergoing rehabilitation consistent with the current standards of care
* Must be able to communicate clearly in English
* Must be able to provide consent in writing.
Exclusion Criteria
* Previous surgical procedure to the spinal cord
* Any MRI incompatible devices
* Pregnancy
* Claustrophobia
* Breathing disorder
* Hearing problems or ringing in the ears
* Bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient
* Cognitive deficits, other non-motor neurological impairment, bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient
18 Years
70 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Bin He, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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Clinical and Translational Science Institute
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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CBET-1264562
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1306M36401
Identifier Type: -
Identifier Source: org_study_id
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