Brain-Controlled Spinal Stimulation Walking Therapy After Incomplete Spinal Cord Injury (SCI)

Last updated: March 4, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

BCI-TSCS

Clinical Study ID

NCT06406855
20240091
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this research is to test the effectiveness of a new therapy, called Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS), for improving walking in people with an incomplete spinal cord injury (SCI).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 18 years old and no older than 70 years old at the time of enrollment.

  2. Traumatic incomplete spinal cord injury (neurological level at or above T10 spinalcord level; Abbreviated Injury Scale (AIS) C or D impairment grade for group 1, 3and 4 and AIS B, C or D impairment grade for group 2), who are more than 6 monthspost-injury.

  3. Has detectable motor function in at least 2 muscles per side confirmed by voluntaryElectromyography (EMG) or detectable tibialis anterior (TA) muscle motor evokedpotentials (MEPs) at the baseline assessment.

  4. Able to commit to intensive training and assessment sessions over a maximum totalduration of 6 months.

  5. Could effectively walk overground for at least 10 meters with some assistance of atherapist and minimal body-weight support, with functional spasticity (byparticipant's self-report), functional range-of-motion of lower limb joints, andacceptable bone mass to enable body-weight support, confirmed by Dual-energy X-rayabsorptiometry (DXA) scan.

Exclusion

Exclusion Criteria:

  1. Has traumatic brain injury, stroke, multiple sclerosis, or other neuromusculardisorders that could affect neuromotor function and walking.

  2. Has severe spasticity that could prevent stepping and walking function determined bythe investigator.

  3. Has major executive dysfunction, dementia, depression, neurocognitive impairments,or other major medical co-morbidities.

  4. Has other contra-indications for transcranial magnetic stimulation (TMS) orTranscutaneous Spinal Cord Stimulation (TSCS).

  5. Has a history of recent seizures or poorly managed autonomic dysreflexia that couldbe triggered by TMS or TSCS.

  6. Has a history of prior intracranial surgery or known lesions that would limit TMSassessments and Brain-Computer Interface (BCI) recordings.

  7. Individuals with metal implants in their head and other implantable devices in thebody that could be affected by TMS or TSCS.

  8. Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).

  9. Has urinary tract infection, unhealed fracture, contracture, and pressure sore (Braden Scale).

  10. Has breakdown in skin area that will come into contact with electrodes.

  11. Individuals who require therapy or other care that could interfere withparticipation in the study.

  12. Individuals on investigational drugs or any other intervention known to have apotential impact on neuromotor function.

  13. Individuals with substance disorders, including alcoholism and drug abuse.

  14. Individuals who are pregnant, breastfeeding, or the desire to become pregnant duringthe study.

  15. In the opinion of the investigators, the study is not safe or appropriate for theparticipant.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: BCI-TSCS
Phase:
Study Start date:
May 07, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

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