Brain-controlled therapy for improving walking in people with spinal cord injuries

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

This study is testing a new therapy that uses brain signals and spinal stimulation to help people with partial spinal cord injuries walk better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of Miami (Academic / other)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT06406855 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the effectiveness of a novel therapy combining Brain-Computer Interface (BCI) with Transcutaneous Spinal Cord Stimulation (TSCS) to enhance walking abilities in individuals with incomplete spinal cord injuries. Participants will undergo intensive training and assessment sessions over a period of up to six months. The study focuses on individuals who have some motor function and can walk with assistance, aiming to leverage brain signals to improve mobility. The intervention is designed to be safe and potentially transformative for those affected by spinal cord injuries.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with traumatic incomplete spinal cord injuries who have some detectable motor function.

Not a fit: Patients with complete spinal cord injuries or those unable to participate in intensive training sessions may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve walking capabilities and overall quality of life for patients with incomplete spinal cord injuries.

How similar studies have performed: Other studies utilizing brain-computer interfaces and spinal stimulation have shown promising results, indicating potential for success in this novel approach.

Eligibility criteria

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 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.
3. 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.
4. Able to commit to intensive training and assessment sessions over a maximum total duration of 6 months.
5. 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.

Exclusion Criteria:

1. Has traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking.
2. Has severe spasticity that could prevent stepping and walking function determined by the 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) or Transcutaneous Spinal Cord Stimulation (TSCS).
5. Has a history of recent seizures or poorly managed autonomic dysreflexia that could be triggered by TMS or TSCS.
6. Has a history of prior intracranial surgery or known lesions that would limit TMS assessments and Brain-Computer Interface (BCI) recordings.
7. Individuals with metal implants in their head and other implantable devices in the body 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 with participation in the study.
12. Individuals on investigational drugs or any other intervention known to have a potential 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 during the study.
15. In the opinion of the investigators, the study is not safe or appropriate for the participant.

Where this trial is running

Miami, Florida

• University of Miami — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Matija Milosevic, PhD — University of Miami - MSOM
• Study coordinator: Christina Thruston, DPT

Conditions Spinal Cord Injuries