Spinal Cord InjuryNCT07738978
Understanding and Enhancing Human Health and Movement
A study testing Neural Prosthesis in people with Spinal Cord Injury and Stroke (CVA) or Transient Ischemic Attack, run by Louis Stokes VA Medical Center at 1 site in United States.
Trial summary
By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack, Multiple Sclerosis
- What is being tested?
- Neural Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2021to 21 Mar 2034
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 hypertension
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106
Maura Malenchek, 2167913800 ext. 64989, maura.malenchek@va.gov
About this study
By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.
Read the detailed description
The purpose of this research study is to better understand how people move, so investigators can develop improved ways to help individuals with lower-limb and/or trunk paralysis perform everyday activities such as sitting, reaching, pushing a wheelchair, transferring, standing, stepping, and maintaining balance.
This study evaluates how activating stabilizing muscles, either with surface electrical stimulation or with an implanted neural stimulation device may change the way these daily activities are performed and potentially enhance functional independence.
A key goal of this project is to collect information on the safety and effectiveness of an implanted neural stimulation system. The U.S. Food and Drug Administration (FDA) permits the limited investigational use of this implanted system for individuals with lower-limb and/or trunk paralysis resulting from neurological conditions.
- Being tested
- Neural Prosthesis
- Keywords
- paralysis, electrical stimulation, neuroprosthesis, implanted device
- Medical subject headings
- Spinal Cord Injuries, Stroke, Ischemic Attack, Transient, Multiple Sclerosis, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural ProsthesisDevice
Also called IST-16, IST-12, IRS-8, Spiral Cuff
implanted electrical stimulation device
| Study group | Role | What they receive |
|---|---|---|
| Neural Stimulation | Experimental | This phase includes the use of neural (electrical) stimulation during everyday activities such as sitting, standing, walking, and exercise Receives: Device: Neural Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Max Standing Time
Measured: Study completion - an average of 1 year
Difference in Max Walking distance
Measured: Study completion - an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start21 Mar 2021
- Primary completion21 Mar 2031 (estimated)
- Study completion21 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Nathan Makowski, Louis Stokes VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738978
- Sponsor's protocol ID
- 1591730
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No