Spinal cord stimulation implant guided by MRI after spinal cord injury
Tests an implanted epidural stimulator in 2 people with spinal cord injury.
Key facts
- Who runs it
- University of Colorado, Denver
- Where
- Aurora, United StatesSee the site
- Trial code
- Registry title
- Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury
- Status
- Enrolling by invitation
- People taking part
- 2 people, planned
- Started
- 22 Apr 2026
- Expected to end
- Dec 2027
- Type of study
- Interventional
- Treatments tested
- implanted epidural stimulator
- Record updated
- 8 June 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 long-standing spinal cord injury whose MRI shows some nerve fibers still intact. Two people will get an implanted spinal cord stimulator plus physical therapy to try to restore leg movement.
- Age
- 18 years or older (up to 100 Years)
- Sex
- All sexes can join.
- Disease stage
- Spinal cord injury graded ASIA Impairment Scale B, more than 6 months ago, at level C7 to T8, with signs of upper motor neuron injury. Height 5'1" to 6'3", weight 250 lbs (113 kg) or less. Arms strong enough to handle a walking or standing aid.
- Earlier treatment
- No botox injections into the legs within the past 6 months.
- Biomarker or test result
- MRI must show spared (still intact) spinal cord nerve fibers.
Main reasons for not taking part
- Fear of closed spaces or other reasons you cannot have an MRI
- Unstable or symptomatic heart or lung problems
- Fracture, contractures, pressure sore, blood clot, urinary or other infection within 3 months
- Reasons you cannot have the stimulator implant surgery
- Pregnancy, cauda equina injury, or another nerve disorder besides spinal cord injury
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- American Spinal Injury Association Impairment Scale B spinal cord injury diagnosis
- Beyond 6 months of injury date
- Spinal cord injury at a level range of cervical 7 to thoracic 8 (C7-T8) with signs of upper motor neuron injury
- 18 years or older
- Height 5'1" to 6'3"
- Weight 250 lbs or less
- Sufficient upper extremity strength to manage a stability aide
- Magnetic resonance imaging evidence of spared spinal cord neural fibers
Who cannot take part
- Contraindications to epidural stimulator implantation surgery
- Received botox injections into the lower extremities within the past 6 months
- Recent (within 3 months) history of fracture, contractures, pressure sore, deep vein thrombosis, urinary tract infection, or other infections that might interfere with interventions
- Any other neurological disorder besides spinal cord injury
- Claustrophobia and/or other contraindications to magnetic resonance imaging
- Unstable or symptomatic cardiorespiratory issues, in the opinion of the investigators
- Pregnancy
- Cauda Equina injury
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in United States
- University of Colorado AnschutzAurora, United StatesEnrolling by invitation
About the trial
What the trial wants to find out
This proof-of-concept case series will prospectively use magnetic resonance imaging (MRI) evidence of spared spinal cord neural fibers to guide the selection of 2 research participants to receive a surgically implanted epidural stimulator with the goal of restoring voluntary movement after spinal cord injury (SCI).
Read full original descriptionShow less
Because MRI evidence of spared spinal cord neural fibers demonstrated significant relationships with responsiveness to epidural stimulation in SCI in retrospective studies, the proposed study is a traditional feasibility study - a prospective investigation to be used to capture preliminary safety and effectiveness information to determine if MRI can/should be used in planning a future pivotal study.
The group in the trial
- Epidural stimulation with Physical TherapyTreatment being tested
Stimulation parameters will be optimized for each lower extremity and joint movement. During physical therapy sessions, electrode configurations may be adjusted as needed to optimize stimulation frequencies, and voltage intensity ranges to best enable voluntary control of lower extremity (ankle, knee, and hip) flexion and extension, as well as standing. Intensive physical therapy will consist of 3 visits per week over the course of 6 months directed by a licensed physical therapist with over a decade of experience working with individuals with spinal cord injury, and the epidural stimulator will be ON continuously during these sessions. Physical therapy will involve neurorehabilitation to facilitate voluntary lower extremity movement in the presence of stimulation, with the research participants in the supine, seated, and standing positions.
Treatment: implanted epidural stimulator
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
- Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury: Spared Fibers Proof-of-concept Study
- Plain-language title
- Spinal cord stimulation implant guided by MRI after 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.
- Fit questions
- Built from NCT05966896, who can take part
- Record updated
- 8 June 2026