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A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02098265
Recruitment Status : Suspended (Suspended due to COVID-19)
First Posted : March 27, 2014
Last Update Posted : April 6, 2020
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of this research is to determine if two non-invasive brain stimulation techniques, muscle stimulation of the arm and neuro-stimulation through the tongue, can increase the extent of stroke recovery.

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

Detailed Description:

The aim of this study is to determine if functional muscle stimulation, in addition to non-invasive neurostimulation through the tongue (TDU), 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).

Adult stroke patients with upper extremity motor impairments (henceforth "experimental group"), healthy controls, and participants with risk factors for stroke, without upper extremity impairment (allowing them to serve as controls for patients with upper extremity impairments (henceforth "control group")), will be recruited in this study. Half of the participants in the experimental group will be randomly assigned to the EEG-BCI (brain-computer interface) training ("closed-loop") group and will receive training on the BCI task along with muscle and tongue stimulation. The other half of the participants in the experimental group receiving traditional rehab will not receive any kind of FES or tongue stimulation for the first 8-10 weeks of study period and then will start receiving BCI-FES-tongue stimulation rehab therapy.

All participants without UE impairment in Control group 1 will receive 4-6 (minimum 4, up to a maximum of 6) sessions of training on the BCI system and pre- and post MRI and 2 behavioral testing sessions.

Addition of a Control group 2 is consistent with the AHA grants - Twenty four ischemic stroke patients with moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45); no upper extremity injury or conditions that limited use prior to the stroke; and pre-stroke independence with a Modified Rankin Score of 0 or 1), will be recruited in this arm. All participants in this group will receive MR sessions and behavioral testing similar to the Experimental group.

Addition of an Experimental group receiving EEG-BCI-bilateral FES intervention using the recoveriX system: recoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions. Through the EEG-based recoveriX BCI system, the brain receives visual and tactile feedback in real-time, making rehabilitation more effective. A stroke patient imagines a hand movement while receiving visual feedback through a virtual avatar, and tactile feedback through electrical muscle stimulation paired to the patient's imagined movement, with the aim that these patients might regain the volitional ability to grasp following therapy. Unlike the current EEG-BCI-FES intervention that involves stimulation of only the impaired arm, with recoveriX, both arms are simultaneously stimulated during the course of the intervention.

Specific Aims

To determine if functional muscle stimulation of the arms, in addition to non-invasive neurostimulation through the tongue (TDU), directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery as measured by behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI).

Primary objective

  • To examine the effect of EEG guided functional muscle stimulation on improvement in upper extremity function

Secondary objective

  • To examine plasticity changes as measured by EEG/fMRI measures before and after EEG guided functional muscle stimulation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
Actual Study Start Date : June 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group - Immediate BCI Therapy
EEG - BCI training (closed loop)
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 participant'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

Device: BCI-FES
Experimental: Experimental Group - Delayed BCI Therapy
Scanned and tested 4 times over a 10-week period before EEG-BCI training
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 participant'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

Other: Delay
10 week delay before intervention

Device: BCI-FES
Experimental: Experimental Group - RecoveriX
Recruited from participants who have completed the study intervention
Other: RecoveriX
RecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions.

Active Comparator: Control Group 1
48 stroke patients, 48 participants with risk factors for stroke, 48 healthy controls receiving 4-6 training sessions on the EEG-BCI, pre- and post- behavioral testing, and MRI
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 participant'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

Device: BCI-FES
Active Comparator: Control Group 2
24 Stroke Patients with UE impairment receiving standard FES only therapy
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.




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. ARAT will be assessed at baseline and end of study (approximately 4 months)


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 MRI [ Time Frame: 4 months ]
    To compare the percent signal change in the functional MRI activations before and after functional stimulation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (Experimental Group):

  • Stroke patients with persistent upper extremity (UE) deficits

Inclusion Criteria (Control Group 1)

  • Stroke patients without UE impairments
  • Participants with risk factors for stroke
  • healthy controls

    • No known neurologic, psychiatric or developmental disability

Inclusion Criteria (Control Group 2)

  • Stroke patients with persistent upper extremity (UE) deficits
  • Moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45)
  • No upper extremity injury or conditions that limited use prior to the stroke
  • Pre-stroke independence with a Modified Rankin Score of 0 or 1, for the standard FES only intervention.

Exclusion Criteria (for all participants):

  • Allergic to electrode gel, surgical tape and metals
  • Participants under treatment for infectious diseases or having apparent oral lesions or inflammation will be excluded from the study
  • Women who are pregnant or may become pregnant during the course of the study will be excluded
  • Participants with contraindications for MRI will be offered the opportunity to participate in the interventions study only (e.g. EEG-BCI-FES and behavioral testing)

Exclusion Criteria (for healthy controls)

  • Contraindications for MRI
  • Allergic to electrode gel, surgical tape, and metals.

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


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
American Heart Association
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    
Other Study ID Numbers: 2015-0469
A539300 ( Other Identifier: UW Madison )
SMPH/RADIOLOGY ( Other Identifier: UW Madison )
15GRNT25780033 ( Other Grant/Funding Number: American Heart Association )
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: April 6, 2020
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
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