Clinical trial NCT04141774: Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology
Official title: Stroke Rehabilitation Using BCI Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: aneurysm
transient ischemic attack
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2019-10-28
Enrollment: 84
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine if functional muscle stimulation, directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Participants will include stroke patients with upper-limb hemiparesis and can expect to be on study for approximately 4 months.

Detailed description: Ongoing research (NCT02098265) suggests that noninvasive EEG driven Brain Computer Interface (BCI) systems hold the potential for facilitating recovery in the chronic phase after stroke by synchronizing central or brain activity with peripheral movements and thereby harnessing brain plasticity.

The specific aims of this study are:

Aim 1: To investigate the efficacy of active FES vs. passive FES, as measured by changes in behavioral measures. The investigators hypothesize that improvements in motor function will be significantly greater using the active FES therapy than the passive FES therapy.

Aim 2: To investigate the relationship between brain functional activation patterns and behavior changes induced by active vs. passive FES intervention. The investigators hypothesize that changes induced by active FES (as measured by brain fMRI and EEG measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive FES.

Aim 3: To investigate the relationship between brain white matter integrity and behavior changes induced by active vs. passive FES intervention. The investigators hypothesize that changes induced by active FES (as measured by brain DTI measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive FES.

Eligibility criteria: Inclusion Criteria:

* New-onset ischemic stroke 12 months prior - chronic time frame;
* Right hand dominant - affected arm;
* Mild to moderate unilateral upper extremity impairment or severe unilateral upper extremity impairment;
* No upper extremity injury or conditions that limited use prior to the stroke;
* Must be able to provide informed consent on their own behalf.

Exclusion Criteria:

* Inability to competently participate in study procedures
* Concurrent upper extremity therapy, other neurological or psychiatric disorders

Primary outcomes:
measure: Action Research Arm Test Scores
timeFrame: 4 months
measure: Stroke Impact Scale
timeFrame: 4 months
Secondary outcomes:
measure: Change in Electroencephalogram (EEG) Response Strength
timeFrame: 4 months
measure: Signal Change in Functional Magnetic Resonance Imaging (MRI)
timeFrame: 4 months
measure: Change in Nine Hole Peg Test (9HPT)
timeFrame: 4 months
measure: Change in Motor Activity Log (MAL)
timeFrame: 4 months
measure: Change in Modified Ashworth Scale (MAS)
timeFrame: 4 months
measure: Change in Hand Grip Strength
timeFrame: 4 months
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 4 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Vivek Prabhakaran, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: