Recruiting

Electrical Stimulation

Sponsor:

Louis Stokes VA Medical Center

Code:

NCT07738978

Conditions

Spinal Cord Injury

Stroke (CVA) or Transient Ischemic Attack

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neural Prosthesis

Study Details

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.

Conditions

Spinal Cord Injury

Stroke (CVA) or Transient Ischemic Attack

Multiple Sclerosis

Study ID

NCT07738978

Start date

Mar 21, 2021

Status verified date

Jul, 2026

Completion date

Mar 21, 2034

Anticipated

Primary completion date

Mar 21, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neural Stimulation

This phase includes the use of neural (electrical) stimulation during everyday activities such as sitting, standing, walking, and exercise

Interventions

Neural Prosthesis

implanted electrical stimulation device

Primary outcome measure

  • Difference in Max Standing Time [ Time Frame: Study completion - an average of 1 year ]
  • Difference in Max Walking distance [ Time Frame: Study completion - an average of 1 year ]

Central Contacts and Locations

Central contacts

Maura Malenchek, PTA

216-791-3800maura.malenchek@va.gov

Lisa Lombardo, MPT

2167913800lisa.lombardo2@va.gov

Locations

Louis Stokes Cleveland VA Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Maura Malenchek

2167913800maura.malenchek@va.gov

More Information

Sponsor

Louis Stokes VA Medical Center

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • paralysis
  • electrical stimulation
  • neuroprosthesis
  • implanted device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louis Stokes VA Medical Center on 2026-07-31.