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

NCT06406855 | Recruiting

• 1 other identifier: 20240091
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (5)

• Number of related neurological deterioration (LEMS)

  Lower Extremity Motor Score (LEMS) to assess lower limb muscle function following the American Spinal Injury Association Impairment Scale (ASIA) guidelines. The LEMS evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function).

  up to 12 months

• Number of treatment related incidence of adverse events (AEs)

  Safety will be reported as the incidence of treatment related AEs as assessed by the study doctor

  up to 12 months

• Number of subjects that complete the study

  Safety will be determined by number of subjects that complete the study, as designed.

  up to 12 months

• Walking function using 10 meter walk test (10MWT)

  This is a test of short-distance walking function. The subject will be asked to walk at a comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway. Time is measured in meters per seconds.

  up to 12 months

• Walking function using 6 minute walk test (6MWT)

  The object of the test is to walk as far as possible for 6 minutes. The subject will walk at a normal pace around a marked course for 6 minutes. The subject may stop to rest and begin again at will. The distance covered indicates aerobic fitness. The further a subject walks, the better their cardiovascular condition. Units are measured in meters.

  up to 12 months

Secondary Outcomes (8)

• Mobility measured by Timed Up and Go (TUG) Test

  up to 12 months.

• Balance measured by the Berg Balance Scale (BBS)

  up to 12 months.

• Muscular spasticity measured by the Modified Ashworth Scale (MAS)

  up to 12 months.

• Muscular spasticity measured by the Pendulum Test

  up to 12 months.

• Walking assistance measured by the Walking Index for Spinal Cord Injury Scale (WISCI II)

  up to 12 months

Study Arms (1)

Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS)

EXPERIMENTAL

Subjects will participate in the therapy for up to 12 months

Other: BCI-TSCS

Interventions

BCI-TSCS OTHER

BCI-TSCS therapy, completed 3-4 times per week, that will include activity-based training, with TSCS activated by BCI system detecting movement attempt.

Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old and no older than 70 years old at the time of enrollment.
• 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.
• 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.
• Able to commit to intensive training and assessment sessions over a maximum total duration of 6 months.
• Could effectively walk overground for at least 10 meters with some assistance of a therapist and minimal body-weight support, with functional spasticity (by participant's self-report), functional range-of-motion of lower limb joints, and acceptable bone mass to enable body-weight support, confirmed by Dual-energy X-ray absorptiometry (DXA) scan.

You may not qualify if:

• Has traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking.
• Has severe spasticity that could prevent stepping and walking function determined by the investigator.
• Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
• Has other contra-indications for transcranial magnetic stimulation (TMS) or Transcutaneous Spinal Cord Stimulation (TSCS).
• Has a history of recent seizures or poorly managed autonomic dysreflexia that could be triggered by TMS or TSCS.
• Has a history of prior intracranial surgery or known lesions that would limit TMS assessments and Brain-Computer Interface (BCI) recordings.
• Individuals with metal implants in their head and other implantable devices in the body that could be affected by TMS or TSCS.
• Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
• Has urinary tract infection, unhealed fracture, contracture, and pressure sore (Braden Scale).
• Has breakdown in skin area that will come into contact with electrodes.
• Individuals who require therapy or other care that could interfere with participation in the study.
• Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
• Individuals with substance disorders, including alcoholism and drug abuse.
• Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
• In the opinion of the investigators, the study is not safe or appropriate for the participant.

Sponsors & Collaborators

• University of Miami: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Matija Milosevic, PhD

  University of Miami - MSOM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Thruston, DPT

CONTACT

(305) 243-9301; cst58@med.miami.edu

Matija Milosevic, PhD

CONTACT

(305) 243-3572; mmilosevic@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)