A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/5/2019 |
| Start Date: | March 2014 |
| End Date: | June 2017 |
A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined Repetitive Transcranial Magnetic Stimulation and Brain-Computer Interface Training
The purpose of this study is to determine whether the combination of low frequency repetitive
transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface
(BCI) training is effective for enhancing motor recovery after stroke.
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.
transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface
(BCI) training is effective for enhancing motor recovery after stroke.
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.
The goal of the present study is to develop and evaluate a brain based approach to improve
motor recovery after stroke, by combining rTMS and BCI training. Treatments will consist of
low frequency rTMS applied to the contralesional hemisphere, followed by BCI training to
encourage activity within the lesioned hemisphere. The primary objective of this study is to
test the main hypothesis above in a stroke patient population. Subjects will also undergo a
period of BCI only treatments after completion of the combined rTMS and BCI portion.
motor recovery after stroke, by combining rTMS and BCI training. Treatments will consist of
low frequency rTMS applied to the contralesional hemisphere, followed by BCI training to
encourage activity within the lesioned hemisphere. The primary objective of this study is to
test the main hypothesis above in a stroke patient population. Subjects will also undergo a
period of BCI only treatments after completion of the combined rTMS and BCI portion.
Inclusion Criteria:
- 18-70 years of age
- 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:
- Personal history of epilepsy or seizures within the past 2 years
- 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
We found this trial at
1
site
Minneapolis, Minnesota 55455
Principal Investigator: Bin He, PhD
Phone: 612-626-1114
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