Spinal Cord InjuriesNCT06406855
Brain-Controlled Spinal Stimulation Walking Therapy After Incomplete Spinal Cord Injury (SCI)
A study testing Brain-Computer Interface-Triggered Transcutaneous Spinal Cord Stimulation (BCI-tSCS) System in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Brain-Computer Interface-Triggered Transcutaneous Spinal Cord Stimulation (BCI-tSCS) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 12 months (6 months of treatment).
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain-Controlled Spinal Stimulation Therapy for Restoration of Walking After Incomplete Spinal Cord Injury (SCI)
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
- Being tested
- Brain-Computer Interface-Triggered Transcutaneous Spinal Cord Stimulation (BCI-tSCS) System
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-Computer Interface-Triggered Transcutaneous Spinal Cord Stimulation (BCI-tSCS) SystemDevice
Also called Neostim 5 Spinal Cord Stimulator
Participants will receive brain-computer interface (BCI)-triggered transcutaneous spinal cord stimulation (tSCS) using the Neostim 5 spinal cord stimulator during activity-based training sessions. The BCI system detects movement attempts and triggers delivery of transcutaneous spinal cord stimulation. Intervention sessions will occur 3 to 4 times per week throughout the study intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) | Experimental | Participants will receive brain-computer interface (BCI)-triggered transcutaneous spinal cord stimulation (tSCS) combined with activity-based training 3 to 4 times per week. The BCI system detects movement attempts and triggers stimulation delivered through the Neostim 5 spinal cord stimulator. Participants will participate in the therapy for up to 12 months. Receives: Device: Brain-Computer Interface-Triggered Transcutaneous Spinal Cord Stimulation (BCI-tSCS) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 12 months
Secondary outcomes (8)
Mobility measured by Timed Up and Go (TUG) Test
The Timed Up and Go test or TUG test is used to help evaluate mobility. It measures, in seconds, how long it takes subjects to stand up, walk 10 feet, turn around, walk back, and sit down.
Measured: up to 12 months.
Balance measured by the Berg Balance Scale (BBS)
BBS is an assessment to determine balance. The BBS consists of 14 items scored on a 5-point ordinal scale, ranging from 0 to 4 (0 indicates lowest level of function; 4 indicates highest level of function), with a maximum total score of 56.
Measured: up to 12 months.
Muscular spasticity measured by the Modified Ashworth Scale (MAS)
The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.
Measured: up to 12 months.
Muscular spasticity measured by the Pendulum Test
The Pendulum Test will be used to measure muscular spasticity. During the pendulum test, the participant will be lying on a therapy mat with the lower leg hanging off the edge of the mat. A member of the study staff will support the participant's extended lower leg and then release the leg allowing it to swing freely. This test will be video recorded and the movement of the knee joint will be measured using software on the computer. Muscular spasticity will be calculated by the number of the Relaxation index (R1 and R2) and compared to norms.
Measured: up to 12 months.
Walking assistance measured by the Walking Index for Spinal Cord Injury Scale (WISCI II)
WISCI II is an ordinal scale using a rank ordering along a dimension of impairment, from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons. The order of the levels suggests each successive level is a less impaired level than the former.
Measured: up to 12 months
Independence as measured by Spinal Cord Independence Measure (SCIM III)
SCIM III assesses performance in activities of daily living Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.
Measured: up to 12 months
Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL)
ISCI-QOL consists of three single items on satisfaction with life as a whole, physical health and psychological health using a 0-10 scale where 0=complete dissatisfaction; 10=complete satisfaction.
Measured: up to 12 months
Quality of Life measured by the Reintegration to Normal Living (RNL) questionnaires
RNL is a self-report questionnaire that assesses a person's satisfaction with performance in life activities. The RNL index assesses mobility, self-care, daily activity, recreational activity, and family roles.
The RNL includes 11 declarative statements and a composite score will be calculated. Minimum Score = 0; Maximum Score = 100. Higher scores indicate greater reintegration.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start7 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Matija Milosevic, University of Miami
- Investigators
- Matija Milosevic, PhD, Principal investigator, University of Miami - MSOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406855
- Sponsor's protocol ID
- 20240091
- Status last verified
- Aug 2026
- First submitted
- 6 May 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-Controlled Spinal Stimulation Therapy for Restoration of Walking After Incomplete Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT06406855
- Acronym / sponsor ID
- 20240091
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 7 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) | Experimental | Device: Brain-Computer Interface-Triggered Transcutaneous Spinal Cord Stimulation (BCI-tSCS) SystemParticipants will receive brain-computer interface (BCI)-triggered transcutaneous spinal cord stimulation (tSCS) combined with activity-based training 3 to 4 times per week. The BCI system detects movement attempts and triggers stimulation delivered through the Neostim 5 spinal cord stimulator. Participants will participate in the therapy for up to 12 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 12 months (6 months of treatment).
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain-Computer Interface-Triggered Transcutaneous Spinal Cord Stimulation (BCI-tSCS) SystemAlso: Neostim 5 Spinal Cord StimulatorParticipants will receive brain-computer interface (BCI)-triggered transcutaneous spinal cord stimulation (tSCS) using the Neostim 5 spinal cord stimulator during activity-based training sessions. The BCI system detects movement attempts and triggers delivery of transcutaneous spinal cord stimulation. Intervention sessions will occur 3 to 4 times per week throughout the study intervention period. | Device | Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) |
Primary outcome
Number of related neurological deterioration (LEMS)
Time frame: up to 12 months
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).
Number of treatment related incidence of adverse events (AEs)
Time frame: up to 12 months
Safety will be reported as the incidence of treatment related AEs as assessed by the study doctor
Number of subjects that complete the study
Time frame: up to 12 months
Safety will be determined by number of subjects that complete the study, as designed.
Walking function using 10 meter walk test (10MWT)
Time frame: up to 12 months
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.
Walking function using 6 minute walk test (6MWT)
Time frame: up to 12 months
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.
8 secondary outcomes
Mobility measured by Timed Up and Go (TUG) Test
Time frame: up to 12 months.
Balance measured by the Berg Balance Scale (BBS)
Time frame: up to 12 months.
Muscular spasticity measured by the Modified Ashworth Scale (MAS)
Time frame: up to 12 months.
Muscular spasticity measured by the Pendulum Test
Time frame: up to 12 months.
Walking assistance measured by the Walking Index for Spinal Cord Injury Scale (WISCI II)
Time frame: up to 12 months
Independence as measured by Spinal Cord Independence Measure (SCIM III)
Time frame: up to 12 months
Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL)
Time frame: up to 12 months
Quality of Life measured by the Reintegration to Normal Living (RNL) questionnaires
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matija Milosevic, PhD principal investigator
University of Miami - MSOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-Computer Interface-Triggered Transcutaneous Spinal Cord Stimulation (BCI-tSCS) System in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of related neurological deterioration (LEMS) (time frame: up to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.