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

Spinal Cord Injuries Clinical Trial

— BCI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03098927
• Other study ID #: 14-041
• Status: Withdrawn
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

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