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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03098927
Other study ID # 14-041
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 1, 2014
Est. completion date November 30, 2017

Study information

Verified date April 2024
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 30, 2017
Est. primary completion date November 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motor imagery training
Motor imagery training

Locations

Country Name City State
United States The Cleveland Clinic Cleveland Ohio

Sponsors (3)

Lead Sponsor Collaborator
The Cleveland Clinic MetroHealth Medical Center, National Aeronautics and Space Administration (NASA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in motor imagery performance Improvement in scores on Motor Imagery questionnaire Year 1
Primary Cortical signal generation (Mirror Neuron Network activation) EEG collection of cortical activity to quantify changes and discriminate between different types of executed movements during Motor Imagery Year 2
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