NCT07738978 Understanding and Enhancing Human Health and Movement
| NCT ID | NCT07738978 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Louis Stokes VA Medical Center |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2021-03-21 |
| Primary Completion | 2031-03-21 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2021-03-21 with a primary completion date of 2031-03-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 brain injury.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07738978 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07738978 currently recruiting?
Yes, NCT07738978 is actively recruiting participants. Contact the research team at maura.malenchek@va.gov for enrollment information.
Where is the NCT07738978 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07738978 clinical trial?
NCT07738978 is sponsored by Louis Stokes VA Medical Center. The trial plans to enroll 75 participants.