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Clinical Trials/NCT03098927
NCT03098927
Withdrawn
Not Applicable

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

The Cleveland Clinic1 site in 1 countrySeptember 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
The Cleveland Clinic
Locations
1
Primary Endpoint
Change in motor imagery performance
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2014
End Date
November 30, 2017
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hubert Fernandez

Principal Investigator

The Cleveland Clinic

Eligibility 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.

Outcomes

Primary Outcomes

Change in motor imagery performance

Time Frame: Year 1

Improvement in scores on Motor Imagery questionnaire

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

Study Sites (1)

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