Mind over movement: Brain-Controlled therapy aims to restore walking after spinal injury
NCT ID NCT06406855
First seen Jun 26, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This study tests a new therapy that uses a brain-computer interface to detect when a person tries to move, then activates spinal cord stimulation to help them walk. It is for people with incomplete spinal cord injury who are at least 6 months post-injury. The goal is to see if it is safe and improves walking function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Brain-Computer Interface (BCI) combined with Transcutaneous Spinal Cord Stimulation (TSCS)
- What this could lead to
- If it works, this could point toward a new therapy that helps people with spinal cord injury regain walking ability without surgery.
- What could go wrong
- This is a very early, small study (12 people) focused on safety and feasibility. It may not lead to a proven treatment, and individual results may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Serotonin precursor probed for spinal cord injury effects
- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller
- Zapping the spine: a new hope for kids with paralysis?
- Can painless spinal zaps teach injured kids to walk again?