Improving Movement After Paralysis with an Implanted Neural Stimulation Device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores activating stabilizing muscles through either surface electrical stimulation or an implanted neural device to see if it improves daily movement and independence. It aims to assess safety and effectiveness of the implanted system in people with lower-limb and/or trunk paralysis. Researchers will observe how movements like sitting, standing, transferring, and stepping change with stimulation. The study is conducted under limited FDA investigational use at a VA medical center. Participants will undergo follow-up visits to monitor outcomes and safety.

Why it matters

Who can join: the full rules

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

Where it's running

• Louis Stokes Cleveland VA Medical Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Maura Malenchek, PTA
• Email: maura.malenchek@va.gov
• Phone: 216-791-3800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.