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New treatment option for SCI - Spinal Cord Injury
Official title A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients
ClinicalTrials.gov ID: NCT06494059
What this study is testing
- What it's testing
- The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without 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. Healthy volunteers may be eligible.
You may be able to join if
- Male or Female people
- At least 18 years old and no older than 70 years old at the time of enrollment.
- Able-bodied people
- Traumatic spinal cord injury
- Upper limb target: neurological level at or above Thoracic 1 level, Abbreviated Injury Scale (AIS) B, C or D impairment grade, primary non-ambulatory;
You likely can't join if
- Has traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.
- Has severe spasticity that could prevent the study protocol as determined by the investigator.
- Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
- Has contraindications for transcutaneous stimulation using FES or TSCS such as breakdown of skin in the area that will come into contact with...
- Has a poorly managed autonomic dysreflexia that could be triggered by transcranial magnetic stimulation (TMS), FES, or TSCS.
- Has a history of prior intracranial surgery or known medical risks that would limit TMS protocols.
See the full eligibility criteria
- Male or Female people
- At least 18 years old and no older than 70 years old at the time of enrollment.
- Able-bodied people
- Traumatic spinal cord injury
- Upper limb target: neurological level at or above Thoracic 1 level, Abbreviated Injury Scale (AIS) B, C or D impairment grade, primary non-ambulatory;
- Lower limb target: neurological level at or above Thoracic 10 level, with residual lower limb function; AIS B, C or D impairment grade primary could ambulate;
- Trunk target: neurological at or above Thoracic 5, AIS A, B, C or D impairment grade, primary wheelchair user
- Spinal cord injury sustained more than 6 months prior to study.
- Movement/excitability/etc:
- Upper limb target: Has detectable residual connection in upper-limb muscles in at least one side confirmed by voluntary electromyography (EMG) or detectable motor evoked potential (MEP) and a visible contraction when...
- Lower limb target: Has detectable residual connection in lower-limb muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in lower limb ankle plantar or...
- Trunk target: Has detectable residual connection in trunk muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in trunk muscle at baseline.
- Able to commit to intervention and assessment sessions over a maximum duration of 2 months.
- Has traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.
- Has severe spasticity that could prevent the study protocol as determined by the investigator.
- Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
- Has contraindications for transcutaneous stimulation using FES or TSCS such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease.
- Has a poorly managed autonomic dysreflexia that could be triggered by transcranial magnetic stimulation (TMS), FES, or TSCS.
- Has a history of prior intracranial surgery or known medical risks that would limit TMS protocols.
- Has a history of epilepsy, convulsion or seizures.
- Individuals with metal implants in their head or spine near the sites to be stimulated and other implantable devices (e.g., cochlear implants) in the body that could be affected by TMS or TSCS.
- Has implanted neurostimulator (e.g., deep brain stimulation (DBS), epidural/subdural, vagal nerve stimulation or VNS).
- Has a cardiac pacemaker or intracardiac lines.
- Has peripheral neuropathy, including diabetic polyneuropathy and entrapment neuropathy.
- Has urinary tract infection, unhealed fracture, contracture, and pressure sore as determined by Braden Scale value of 14 and below.
- 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. Healthy volunteers may be eligible. 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.