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

NeuroTherapia, Inc.

Status: Withdrawn

Conditions: Spinal Cord Injuries

Treatments: Behavioral: Motor imagery training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03098927

14-041

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Early intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Motor imagery training

Late intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Motor imagery training