Understanding and Enhancing Human Health and Movement

NCT07738978 | Recruiting DMC FDA Device

• 1 other identifier: 1591730
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

paralysis; electrical stimulation; neuroprosthesis; implanted device

Outcome Measures

Primary Outcomes (2)

• Difference in Max Standing Time

  Study completion - an average of 1 year

• Difference in Max Walking distance

  Study completion - an average of 1 year

Study Arms (1)

Neural Stimulation

EXPERIMENTAL

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

Device: Neural Prosthesis

Interventions

Neural Prosthesis DEVICE

implanted electrical stimulation device

Also known as: IST-16, IST-12, IRS-8, Spiral Cuff

Neural Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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, 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

You may not qualify 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 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

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead

Study Sites (1)

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke; Ischemic Attack, Transient; Multiple Sclerosis; Paralysis

Interventions

Neural Prostheses

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants

Central Study Contacts

Maura Malenchek, PTA

CONTACT

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

Lisa Lombardo, MPT

CONTACT

2167913800; lisa.lombardo2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 31, 2026
• Study Start: March 21, 2021
• Primary Completion (Estimated): March 21, 2031
• Study Completion (Estimated): March 21, 2034
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)