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

NCT03098927 | Withdrawn

• 1 other identifier: 14-041
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Motor Imagery; Spinal Cord Injury; Motor Function Improvement

Outcome Measures

Primary Outcomes (2)

• Change in motor imagery performance

  Improvement in scores on Motor Imagery questionnaire

  Year 1

• 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

Study Arms (2)

Early intervention

ACTIVE COMPARATOR

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

Late intervention

ACTIVE COMPARATOR

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

Interventions

Motor imagery training BEHAVIORAL

Motor imagery training

Early intervention; Late intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Aeronautics and Space Administration (NASA): collaborator
• MetroHealth Medical Center: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Darlene Lobel, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: April 4, 2017
• Study Start: September 1, 2014
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)