Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06406855

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

Led by University of Miami · Updated on 2025-09-12

12

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old and no older than 70 years at enrollment
  • Traumatic incomplete spinal cord injury at or above T10 spinal level, more than 6 months post-injury
  • Motor function detectable in at least 2 muscles per side by voluntary Electromyography or tibialis anterior muscle motor evoked potentials
  • Able to commit to intensive training and assessments over a maximum of 6 months
  • Able to walk at least 10 meters with some therapist assistance and minimal body-weight support, with functional spasticity, range of motion, and acceptable bone mass confirmed by scans
Not Eligible

You will not qualify if you...

  • Traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders affecting walking
  • Severe spasticity preventing stepping or walking
  • Major executive dysfunction, dementia, depression, neurocognitive impairments, or major medical co-morbidities
  • Contraindications for transcranial magnetic stimulation or transcutaneous spinal cord stimulation
  • Recent seizures or poorly managed autonomic dysreflexia triggered by stimulation
  • History of intracranial surgery or lesions limiting brain or BCI assessments
  • Metal implants in head or other implantable devices affected by stimulation
  • Peripheral neuropathy such as diabetic or entrapment neuropathy
  • Urinary tract infection, unhealed fractures, contractures, or pressure sores
  • Skin breakdown where electrodes will be placed
  • Need for other therapies or care interfering with study participation
  • Use of investigational drugs or other interventions affecting neuromotor function
  • Substance abuse including alcoholism or drug abuse
  • Pregnancy, breastfeeding, or plans to become pregnant during the study
  • Investigator judgment deeming the study unsafe or inappropriate for the participant

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

C

Christina Thruston, DPT

CONTACT

M

Matija Milosevic, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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