A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training

Completed · Not applicable · Has a placebo group

Conditions studied: Hemiparesis, Stroke

In brief

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.

Key facts

Study ID

NCT02132520

Run by

University of Minnesota

People needed

3

Starts

2014-03-01

Expected to finish

2017-06-01

Last updated by the study team

2019-11-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Clinical and Translational Science Institute — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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