Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
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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