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

NCT ID: NCT03098927

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2017-11-30

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Motor imagery training

Intervention Type: BEHAVIORAL

Motor imagery training

Late intervention

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

Group Type: ACTIVE_COMPARATOR

Motor imagery training

Intervention Type: BEHAVIORAL

Motor imagery training

Interventions

Motor imagery training

Motor imagery training

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Aeronautics and Space Administration (NASA)

FED

Sponsor Role: collaborator

MetroHealth Medical Center

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Hubert Fernandez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darlene Lobel, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

The Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

14-041

Identifier Type: -

Identifier Source: org_study_id