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Mirror Neuron Network Based Motor Imagery Training to Improve Brain Computer Interface Performance in Spinal Cord Injury Patients (BCI)

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ClinicalTrials.gov Identifier: NCT03098927
Recruitment Status : Withdrawn (Two subjects finally recruited 11/17, but not enough time to complete their studies before the funding terminated on November 30, 2017)
First Posted : April 4, 2017
Last Update Posted : December 14, 2017
Sponsor:
Collaborators:
National Aeronautics and Space Administration (NASA)
MetroHealth Medical Center
Information provided by (Responsible Party):
Darlene A. Lobel, MD, The Cleveland Clinic

Brief Summary:
The overall vision of this proposal is to demonstrate that a virtual reality based motor imagery training program will improve brain computer interface (BCI) performance and motor function in quadriplegic subjects. The ultimate goal is to increase the independence of subjects with spinal cord injury by training to safely control BCI assistive devices and to enhance motor recovery.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Motor imagery training Not Applicable

Detailed Description:

Intend to train subjects in motor imagery techniques using an advanced virtual reality based platform. Hypothesize that this will enhance the cortical signals necessary for operating a non-invasive EEG-based BCI. Specifically, designed training paradigms will activate "mirror neurons" associated with performance of movement, observation of movement, and motor imagery. Mirror neuron network (MNN) activation induces cortical plasticity, and may therefore enhance cortical signals generated during BCI use. Plan to assess the effect of training paradigm on cortical signals generated during motor imagery, using EEG. Also, investigate neuropsychological factors that play a role in a subject's ability to generate vivid motor imagery.

Eight subjects with spinal cord injury (SCI) will be recruited during the sub-acute phase (3-6 months following injury). Four participants will immediately undergo motor imagery training in an immersive virtual reality environment at NASA. EEG assessments and motor function testing will be performed at intervals during the 3-4 week motor imagery training period to assess improvement in cortical signature generation and motor recovery. The other four participants will undergo the same protocol after a 6 week delay, in order to assess the effect of training timing after injury in both cortical signature generation and motor function recovery.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Eight subjects with spinal cord injury (SCI) will be recruited during the sub-acute phase (3-6 months following injury). Four participants will immediately undergo motor imagery training in an immersive virtual reality environment at NASA. EEG assessments and motor function testing will be performed at intervals during the 3-4 week motor imagery training period to assess improvement in cortical signature generation and motor recovery. The other four participants will undergo the same protocol after a 6 week delay, in order to assess the effect of training timing after injury in both cortical signature generation and motor function recovery.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mirror Neuron Network Based Motor Imagery Training Paradigms to Improve Brain Computer Interface (BCI) Performance in Spinal Cord Injury Patients
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Early intervention
Early intervention patients will undergo 3 weeks of motor imagery training immediately upon enrolling in the study between 3 and 6 months post spinal cord injury.
Behavioral: Motor imagery training
Motor imagery training

Active Comparator: Late intervention
Late intervention patients will undergo 3 weeks of motor imagery training after 6 weeks of standard of care physical rehabilitation following enrollment.
Behavioral: Motor imagery training
Motor imagery training




Primary Outcome Measures :
  1. Change in motor imagery performance [ Time Frame: Year 1 ]
    Improvement in scores on Motor Imagery questionnaire

  2. Cortical signal generation (Mirror Neuron Network activation) [ Time Frame: Year 2 ]
    EEG collection of cortical activity to quantify changes and discriminate between different types of executed movements during Motor Imagery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sustained incomplete Spinal Cord Injury (American Spinal Injury Impairment Scale) at a level of C5-7 within three to six months prior to enrollment

Exclusion Criteria:

  • unstable or acute medical or psychiatric illness; pregnancy; epilepsy; diabetes; autism spectrum disorder, history of severe traumatic brain injury or stroke, and those taking medications that may interfere with EEG readings, including beta blockers and sedatives.

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): NCT03098927


Locations
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United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Aeronautics and Space Administration (NASA)
MetroHealth Medical Center
Investigators
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Principal Investigator: Darlene Lobel, MD The Cleveland Clinic

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Responsible Party: Darlene A. Lobel, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03098927     History of Changes
Other Study ID Numbers: 14-041
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
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: No
Keywords provided by Darlene A. Lobel, MD, The Cleveland Clinic:
Motor Imagery
Spinal Cord Injury
Motor Function Improvement
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System