Spinal Cord Injury study: Neural Prosthesis
Official title Understanding and Enhancing Human Health and Movement
ClinicalTrials.gov ID: NCT07738978
What this study is testing
- What it's testing
- This study is testing whether an implanted electrical stimulation system can improve movement and function after paralysis from spinal cord injury, stroke, or multiple sclerosis.
- Who it's for
- You may be able to join if you have paralysis from spinal cord injury, stroke, or multiple sclerosis.
- What's involved
- You would have a small device implanted that sends gentle electrical signals to your nerves. You will have regular check‑ins and tests to see how well it works and if it is safe.
- Time commitment
- The study lasts about a year, with several visits over that time to monitor your progress.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Skeletal maturity and ability to sign informed consent (\>18 years)
- Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis...
- Innervated and excitable lower extremity and trunk musculature
- Adequate social support and stability
- Willingness to comply with follow-up procedures
You likely can't join if
- Non-English speaking
- Females who are pregnant
- Current pressure injuries that would be exacerbated by study activities
- Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would...
- History of spontaneous fractures or other evidence of excessively low bone density
- History of vestibular dysfunction, balance problems, or spontaneous falls
See the full eligibility criteria
- Skeletal maturity and ability to sign informed consent (\>18 years)
- Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
- Innervated and excitable lower extremity and trunk musculature
- Adequate social support and stability
- Willingness to comply with follow-up procedures
- Time post injury greater than six months
- Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
- Neurologically stable as determined by a physician
- Non-English speaking
- Females who are pregnant
- Current pressure injuries that would be exacerbated by study activities
- Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
- History of spontaneous fractures or other evidence of excessively low bone density
- History of vestibular dysfunction, balance problems, or spontaneous falls
- Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.
- Acute and/or chronic problems left untreated or not controlled that would put a participant at risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise, diabetes or...
- Presence of a demand pacemaker or cardiac defibrillator
- Any other medical or psychological condition that would be a contraindication
- Current pressure ulcers
- Significant range of motion limitations that would compromise study activities
- Body habitus that would compromise study activities
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, 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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.