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WithdrawnNCT03098927BCIUpdated Apr 15, 2024

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

An interventional study of Motor imagery training in Spinal Cord Injuries, sponsored by The Cleveland Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-04-15.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Two subjects finally recruited 11/17, but not enough time to complete their studies before the funding terminated on November 30, 2017

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Sep 2014, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Spinal Cord Injuries

Keywords

  • Motor Imagery
  • Spinal Cord Injury
  • Motor Function Improvement
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

Browse Spinal Cord Injuries studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    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.

    Behavioral: Motor imagery training

  • Active comparator
    Late intervention

    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

  • BehavioralMotor imagery training

    Motor imagery training

06

What researchers measure

Primary outcomes

  1. Change in motor imagery performance

    Improvement in scores on Motor Imagery questionnaire

    Time frame: Year 1

  2. 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

    Time frame: Year 2

07

Study locations

1 site
  • The Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03098927
Lead sponsor
The Cleveland Clinic
Collaborators
National Aeronautics and Space Administration (NASA), MetroHealth Medical Center
Responsible party
Hubert Fernandez (Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
Apr 4, 2017
Start date
Sep 1, 2014
Primary completion
Nov 30, 2017
Completion
Nov 30, 2017
Last update
Apr 15, 2024

Study contacts

Darlene Lobel, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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