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A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

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ClinicalTrials.gov Identifier: NCT02098265
Recruitment Status : Suspended (Suspended due to COVID-19)
First Posted : March 27, 2014
Last Update Posted : December 21, 2020
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE March 6, 2014
First Posted Date  ICMJE March 27, 2014
Last Update Posted Date December 21, 2020
Actual Study Start Date  ICMJE June 2010
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
Efficacy [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • Functional [ 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.
  • Functional [ Time Frame: 4 months ]
    To compare the percent signal change in the functional MRI activations before and after functional stimulation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
Official Title  ICMJE A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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 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: RecoveriX
    RecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions.
  • Other: Delay
    10 week delay before intervention
  • Device: BCI-FES
Study Arms  ICMJE
  • Experimental: Experimental Group - Immediate BCI Therapy
    EEG - BCI training (closed loop)
    Interventions:
    • Behavioral: Behavioral Assessments
    • Other: Magnetic Resonance Imaging
    • Other: EEG
    • Device: BCI-FES
  • Experimental: Experimental Group - Delayed BCI Therapy
    Scanned and tested 4 times over a 10-week period before EEG-BCI training
    Interventions:
    • Behavioral: Behavioral Assessments
    • Other: Magnetic Resonance Imaging
    • Other: EEG
    • Other: Delay
    • Device: BCI-FES
  • Experimental: Experimental Group - RecoveriX
    Recruited from participants who have completed the study intervention
    Intervention: Other: RecoveriX
  • 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
    Interventions:
    • Behavioral: Behavioral Assessments
    • Other: Magnetic Resonance Imaging
    • Other: EEG
    • Device: BCI-FES
  • Active Comparator: Control Group 2
    24 Stroke Patients with UE impairment receiving standard FES only therapy
    Intervention: Device: Functional Electric Stimulation (FES)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 15, 2019)
288
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2014)
49
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02098265
Other Study ID Numbers  ICMJE 2015-0469
A539300 ( Other Identifier: UW Madison )
SMPH/RADIOLOGY ( Other Identifier: UW Madison )
15GRNT25780033 ( Other Grant/Funding Number: American Heart Association )
August 10, 2019 ( Other Identifier: Protocol Version Date )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE American Heart Association
Investigators  ICMJE
Principal Investigator: Vivek Prabhakaran, MD, PhD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP