Implanted electrical system aims to restore movement in paralyzed limbs
NCT ID NCT00623389
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This study tests a surgically implanted device that uses mild electrical pulses to stimulate muscles in the legs and trunk. The goal is to help people with paralysis from spinal cord injury, stroke, or other conditions exercise, stand, step, and improve balance. Ten participants will receive the implant and undergo physical therapy, with researchers measuring how long they can stand and how far they can walk over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Implanted Stimulator-Telemeter (IST) device with functional electrical stimulation
- What this could lead to
- If successful, this implanted system could help people with paralysis stand, walk short distances, and improve daily function without relying on caregivers.
- What could go wrong
- This is a very small early-stage trial with only 10 participants. The device requires surgery and may not work for everyone. Risks include infection, device failure, or no improvement in function.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2018
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Phase I Inclusion Criteria 1. Skeletal maturity and ability to sign informed consent (\>18 years) 2. 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 3. Innervated and excitable lower extremity and trunk musculature 4. Adequate social support and stability 5. Willingness to comply with follow-up procedures Phase I Exclusion Criteria 1. Non-English speaking 2. Females who are pregnant 3. Current pressure injuries that would be exacerbated by study activities 4. 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 5. History of spontaneous fractures or other evidence of excessively low bone density 6. History of vestibular dysfunction, balance problems, or spontaneous falls 7. Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Louis Stokes Cleveland VA Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
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MetroHealth System
RECRUITINGCleveland, Ohio, 44109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Effects of transcranial direct current stimulation and pelvic proprioceptive neuromuscular facilitation on trunk control, balance and functional mobility in stroke patients
- Correlation of visual and motor deficits in stroke patients
- Transcutaneous spinal stimulation with intensive physical therapy for locomotion
- Simulator-Based assessment of driving performance in patients with Parkinson's disease and multiple sclerosis
- Contrasting chronic inflammation and neurodegeneration using the human amniotic mesenchymal cell secretome as an innovative therapeutic strategy
- Pilot study on the effects induced by an electromyographic-controlled functional electrical stimulator (FitFES) for upper limb rehabilitation in post-stroke patients