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Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

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ClinicalTrials.gov Identifier: NCT04141774
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Stroke Device: Functional Electric Stimulation (FES) Behavioral: Behavioral Assessments Other: Magnetic Resonance Imaging Other: EEG Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stroke Rehabilitation Using BCI Technology
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


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 Name: Electroencephalography




Primary Outcome Measures :
  1. Action Research Arm Test Scores [ Time Frame: 4 months ]
    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.

  2. Stroke Impact Scale [ Time Frame: 4 months ]
    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.


Secondary Outcome Measures :
  1. Change in Electroencephalogram (EEG) Response Strength [ Time Frame: 4 months ]
    The change in the strength of the EEG response before and after functional stimulation during left arm imagery with respect to right arm imagery.

  2. Signal Change in Functional Magnetic Resonance Imaging (MRI) [ Time Frame: 4 months ]
    To compare the percent signal change in the functional MRI activations before and after functional stimulation.

  3. Change in Nine Hole Peg Test (9HPT) [ Time Frame: 4 months ]
    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. Change in Motor Activity Log (MAL) [ Time Frame: 4 months ]
    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.

  5. Change in Modified Ashworth Scale (MAS) [ Time Frame: 4 months ]
    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.

  6. Change in Hand Grip Strength [ Time Frame: 4 months ]
    Hand Grip Strength will be assessed using a dynamometer. Measured at 5 time points over the length of the study.

  7. Change in Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 4 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141774


Contacts
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Contact: Gemma Gliori, MS 608-262-7269 ggliori@uwhealth.org
Contact: Suzanne Hanson, BS 608-263-7421 shanson@uwhealth.org

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53706
Contact: Matthew Giles, BS    608-265-8057    mpgilles@wisc.edu   
Contact: Veena Nair, PhD    608-265-5269    vnair@uwhealth.org   
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Vivek Prabhakaran, MD, PhD University of Wisconsin, Madison

Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04141774     History of Changes
Other Study ID Numbers: 2018-0971
1R01NS105646-01A1 ( U.S. NIH Grant/Contract )
A539300 ( Other Identifier: UW Madison )
SMPH/RADIOLOGY ( Other Identifier: UW Madison )
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Wisconsin, Madison:
aneurysm
transient ischemic attack
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases