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Stroke Rehabilitation Using BCI Technology

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ClinicalTrials.gov Identifier: NCT02098265
Recruitment Status : Recruiting
First Posted : March 27, 2014
Last Update Posted : December 24, 2018
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).

Condition or disease Intervention/treatment Phase
Stroke Device: Functional Electric Stimulation (FES) Behavioral: Behavioral Assessments Other: Magnetic Resonance Imaging Other: EEG Not Applicable

Detailed Description:
The aim of this study is to determine if functional muscle stimulation, in addition to non-invasive neurostimulation, directed by EEG output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging. Our ongoing research 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.

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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
Study Start Date : June 2010
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2022

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 results [ Time Frame: 4 months ]
    Comparison of behavioral test scores obtained before and after the intervention, that are designed for evaluation of upper extremity function, will be the primary outcome measure in this study.


Secondary Outcome Measures :
  1. EEG response strength [ Time Frame: 4 months ]
    Secondary outcomes include measuring 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 MRI [ Time Frame: 4 month ]
    To compare the percent signal change in the functional MRI activations before and after functional stimulation.



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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:

  • Contraindications to MRI
  • Allergies to electrode gel, surgical tape, or metals
  • Pregnancy
  • Current treatment for infectious disease
  • Active oral lesions or inflammation.

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): NCT02098265


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: Theresa Kang, BS    608-262-4033    tkang@uwhealth.org   
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02098265     History of Changes
Other Study ID Numbers: 2018-0971
1R01NS105646-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data with participants.

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