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

University of Minnesota (UMN)

Status: Completed

Conditions: Stroke; Hemiparesis

Treatments: Device: rTMS; Behavioral: BCI Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02132520

CBET-1264562 (Other Grant/Funding Number)

1306M36401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 3 patient groups

Control

No Intervention group

Description:

Subjects receiving standard-of-care physical therapy only.

Sham rTMS + Real BCI Training

Sham Comparator group

Description:

Subjects will receive sham rTMS followed by real BCI training.

Treatment:

Device: rTMS

Behavioral: BCI Training

Real rTMS + Real BCI Training

Active Comparator group

Description:

Subjects will receive real rTMS followed by real BCI training.

Treatment:

Device: rTMS

Behavioral: BCI Training