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New treatment option for Spinal Cord Injuries
Official title Brain-Controlled Spinal Stimulation Walking Therapy After Incomplete Spinal Cord Injury (SCI)
ClinicalTrials.gov ID: NCT06406855
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
- Has detectable motor function in at least 2 muscles per side confirmed by voluntary Electromyography (EMG) or detectable tibialis anterior (TA)...
- 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...
You likely can't join 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.
See the full eligibility criteria
- 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)...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.