Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

Stroke Rehabilitation Using BCI Technology

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Functional Electric Stimulation (FES); Behavioral: Behavioral Assessments; Other: Magnetic Resonance Imaging; Other: EEG

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.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gemma Gliori, MS; Phone Number: 608-262-7269; Email: ggliori@uwhealth.org
• Study Contact Backup: Name: Suzanne Hanson, BS; Phone Number: 608-263-7421; Email: shanson@uwhealth.org

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • Recruiting
      • University of Wisconsin
      • Contact: Sarah Heitmeier, BS; Phone Number: 608-262-7115; Email: sheitmeier@wisc.edu
      • Contact: Veena Nair, PhD; Phone Number: 608-265-5269; Email: vnair@uwhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Passive FES; Subjects randomized to this control group will be asked to participate in a passive FES intervention or non-EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, and functional electric stimulation (FES) treatment.	Device: Functional Electric Stimulation (FES); FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.; Behavioral: Behavioral Assessments; These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.; Other: Magnetic Resonance Imaging; A functional magnetic resonance image will be collected.
Experimental: Active FES; Subjects randomized to this experimental group will be asked to complete the active FES intervention which include EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, functional electric stimulation (FES) treatment, and EEG.	Device: Functional Electric Stimulation (FES); FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.; Behavioral: Behavioral Assessments; These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.; Other: Magnetic Resonance Imaging; A functional magnetic resonance image will be collected.; Other: EEG; EEG electrodes will be attached to the subject's scalp using a standard, commercially available electrode cap. Proper electrode placement is made according to the international 10-20 system, ensuring complete electrode coverage over sensorimotor cortex.; Other Names: Electroencephalography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test Scores	The Action Research Arm Test (ARAT) is designed for evaluation of upper extremity function. This test consists of sections for Grasp, Grip, Pinch and Gross Movements and comprise a total of 19 tests. Each test is scored 0-3 where 0 is 'no movement' and 3 is 'the movement is performed normally'. Each section is scored separately and the scores added for a total possible range of scores from 0-57 where the higher the score, the complete and efficient the movement. Scores will be reported for baseline, mid (~7 weeks), post (~10 weeks), and end of study, up to 4 months.	4 months
Stroke Impact Scale	The Stroke Impact Scale, or SIS, was created to assess changes in impairments, activities and participation following a stroke. Scores on the SIS will provide an index of clinically "meaningful" change representing the change in the patient's mental and physical abilities concurrent with their performance on the verbal fluency and memory tasks. The 4 physical function domains (strength, hand function, activities of daily living (ADL)/instrumental activities of daily living (IADL), and mobility) will be collapsed to a physical function subscale. All domain scores range from 0 to 100 with 100 being the best.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Electroencephalogram (EEG) Response Strength	The change in the strength of the EEG response before and after functional stimulation during left arm imagery with respect to right arm imagery.	4 months
Signal Change in Functional Magnetic Resonance Imaging (MRI)	To compare the percent signal change in the functional MRI activations before and after functional stimulation.	4 months
Change in Nine Hole Peg Test (9HPT)	The 9-HPT is a quick and easy to administer tool for screening fine motor problems in participants. It is a timed test in which nine pegs are inserted and removed from nine holes in the pegboard with each hand. Measured at 5 time points over the length of the study.	4 months
Change in Motor Activity Log (MAL)	The MAL is a structured interview developed to assess the use of the more affected upper extremity (UE) in real-world daily activities. Assessed at 5 time points over the length of the study.	4 months
Change in Modified Ashworth Scale (MAS)	The MAS measures spasticity where 0 is no increase in muscle tone to 4 where affected part is in rigid in flexion or extension. Assessed at 5 time points over the length of the study.	4 months
Change in Hand Grip Strength	Hand Grip Strength will be assessed using a dynamometer. Measured at 5 time points over the length of the study.	4 months
Change in Center for Epidemiologic Studies Depression Scale (CES-D)	The CES-D is a self-report scale and includes 20 items that survey mood, somatic complaints, interactions with others, and motor functioning in the past week. Total possible score 0-60, with the higher score indicating more symptoms of depression. Assessed at 5 time points over the length of the study.	4 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Vivek Prabhakaran, MD, PhD, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• Publication resulting from this work.
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Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2018
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: aneurysm; transient ischemic attack
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2018-0971; A539300 (Other Identifier: UW Madison); 1R01NS105646-01A1 (U.S. NIH Grant/Contract); SMPH/RADIOLOGY (Other Identifier: UW Madison); Protocol Version 2/1/22 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No