← Back to Search

Behavioural Intervention

Brain-Controlled Spinal Stimulation for Spinal Cord Injury

N/A
Recruiting
Led By Matija Milosevic, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has detectable motor function in at least 2 muscles per side confirmed by voluntary Electromyography (EMG) or detectable tibialis anterior (TA) muscle motor evoked potentials (MEPs) at the baseline assessment
Traumatic incomplete spinal cord injury (neurological level at or above T10 spinal cord level; Abbreviated Injury Scale (AIS) C or D impairment grade for group 1, 3 and 4 and AIS B, C or D impairment grade for group 2), who are more than 6 months post-injury
Must not have
Has other contra-indications for transcranial magnetic stimulation (TMS) or Transcutaneous Spinal Cord Stimulation (TSCS)
Has urinary tract infection, unhealed fracture, contracture, and pressure sore (Braden Scale)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Summary

This trial aims to test a new therapy called Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) to see if it can help people with incomplete spinal

Who is the study for?
This trial is for adults aged 21-70 with an incomplete spinal cord injury at or above T10 level, who are more than 6 months post-injury. Participants must have some detectable motor function in their legs and be able to walk at least 10 meters with assistance. They should commit to a 6-month training program and not have metal implants affected by magnetic stimulation, severe spasticity, skin breakdown where electrodes attach, recent seizures, major cognitive issues, or substance disorders.
What is being tested?
The study tests Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) therapy aimed at improving walking ability in people with incomplete SCI. It involves intensive training sessions over six months using BCI-TSCS technology to stimulate the spinal cord and potentially enhance mobility.
What are the potential side effects?
Potential side effects may include discomfort from electrode attachment sites, muscle fatigue due to intensive training sessions, mild headaches or dizziness from transcranial magnetic stimulation (TMS), and possible skin irritation from the electrodes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have muscle movement in at least 2 muscles on each side of my body, confirmed by a muscle test.
Select...
I have a spinal cord injury above T10 and it's been over 6 months since the injury.
Select...
I am between 21 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I don't have conditions that prevent me from having TMS or TSCS.
Select...
I have a urinary tract infection, unhealed fracture, contracture, or pressure sore.
Select...
My severe muscle stiffness prevents me from walking.
Select...
I have broken skin where electrodes would be placed.
Select...
I have had recent seizures or uncontrolled autonomic dysreflexia.
Select...
I have nerve damage, such as diabetic neuropathy.
Select...
I have had brain surgery or have brain lesions that could affect brain assessments.
Select...
I am not on any experimental drugs affecting my muscle control.
Select...
I have a condition like a brain injury or MS that affects my ability to walk.
Select...
I do not have major cognitive or severe health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of related neurological deterioration (LEMS)
Number of subjects that complete the study
Number of treatment related incidence of adverse events (AEs)
+2 more
Secondary outcome measures
Balance measured by the Berg Balance Scale (BBS)
Independence as measured by Spinal Cord Independence Measure (SCIM III)
Mobility measured by Timed Up and Go (TUG) Test
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS)Experimental Treatment1 Intervention
Subjects will participate in the therapy for up to 6 months

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
935 Previous Clinical Trials
422,205 Total Patients Enrolled
Matija Milosevic, PhDPrincipal InvestigatorUniversity of Miami - MSOM
1 Previous Clinical Trials
25 Total Patients Enrolled
~8 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top