Implanted electrical stimulator to steady the trunk in people with spinal cord injury
Tests an implanted stimulator for sitting stability in people with spinal cord injury.
Key facts
- Who runs it
- VA Office of Research and Development
- Where
- Cleveland, United StatesSee the site
- Trial code
- Registry title
- A Neuroprosthesis for Seated Posture and Balance
- Status
- Recruiting
- People taking part
- 10 people, planned
- Started
- 30 Nov 2011
- Expected to end
- 31 Jan 2028
- Type of study
- Interventional
- Treatments tested
- IRS-8 (8-Channel implanted stimulator-telemeter)
- Record updated
- 26 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a spinal cord injury who will get an implanted device. The device uses small electric currents to steady the trunk and hips.
- Age
- 21 years and older
- Sex
- All sexes
- Disease stage
- Spinal cord injury at level C4 to T12, ASIA Scale A through C, more than 6 months after the injury. Trunk and pelvis muscles must still have working nerves and respond to stimulation.
Main reasons for not taking part
- Pregnancy
- Cannot speak and read English
- Acute or chronic psychological problems or chemical dependency
- History of balance problems, spontaneous falls, spontaneous fractures or low bone density
- Uncontrolled spasticity, hip flexion or adduction spasms, or acute orthopaedic or medical problems
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- C4-T12
- ASIA Scale A through C
- Time post injury greater than 6 months
- Innervated and excitable trunk and pelvis musculature
- Absence of acute or chronic psychological problems or chemical dependency
- Range of motion within normal limits
- Controlled spasticity and absence of hip flexion and adduction spasm
- Height and weight within normal limits
- No history of balance problems or spontaneous falls
- No history of spontaneous fracture or evidence low bone density
- No acute orthopaedic problems
- No acute medical complications
- Adequate social support and stability
- Able to speak and read English
Who cannot take part
- Pregnancy
- Non-English speaking
Where in United States
- Louis Stokes VA Medical Center, Cleveland, OHCleveland, United StatesContact: Lisa M Lombardo, MPTTaking people
About the trial
What the trial wants to find out
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.
The group in the trial
- NeuroprosthesisTreatment being tested
Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.
Treatment: IRS-8 (8-Channel implanted stimulator-telemeter)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Neuroprosthesis for Seated Posture and Balance
- Plain-language title
- Implanted electrical stimulator to steady the trunk in people with spinal cord injuryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 26 October 2026