Clinical trial NCT02132520: A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training
Official title: A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined Repetitive Transcranial Magnetic Stimulation and Brain-Computer Interface Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Stroke
Keywords: Hemiparesis
Stroke
Rehabilitation
Transcranial Magnetic Stimulation, Repetitive
Electroencephalography
Functional Neuroimaging
Brain-Computer Interface
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI
timeFrame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
Secondary outcomes:
measure: Changes in Hand Motor Function as Measured by the Box and Block Test
timeFrame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
measure: Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test
timeFrame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
measure: Changes in Inter-hemispheric Inhibition
timeFrame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
Other outcomes:
measure: Subject Report of Symptoms
timeFrame: within 12 weeks of participation
measure: Changes in the Resting Motor Threshold
timeFrame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
Locations:
city: Minneapolis
country: United States
facility: Clinical and Translational Science Institute
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Bin He, PhD
role: PRINCIPAL_INVESTIGATOR
References: