SCI - Spinal Cord InjuryLTONCT05705453
Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
A study testing Epidural Spinal Cord Stimulation in people with SCI - Spinal Cord Injury, run by University of Minnesota at 1 site in United States.
Trial summary
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- Epidural Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2023to 1 Apr 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22 years of age or older
- Able to undergo the informed consent process
- Stable spinal cord injury
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
- No ventilator dependency within the last year
- American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation
Show all 10Show fewer
- Medically stable in the judgment of the Principal investigator
- Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery
- Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation
- Spinal imaging of the stimulator system
Who cannot join
- Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
- Use of botulinum toxin (Botox) injections in the previous six months
- Clinically significant mental illness in the judgment of the principal investigator
- Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
- Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI
- Current Pregnancy
- Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Tara Nash, FNP, 612-873-9113, estand@umn.edu
Study Coordinator, rnl@umn.edu
About this study
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.
Read the detailed description
Participants will be enrolled in this study for the duration of 10 years. They will need to come to Minneapolis twice a year for the Brain Motor Control Assessment and will be given different settings within their Spinal Cord Stimulator (SCS) programing.
- Conditions
- SCI - Spinal Cord Injury
- Being tested
- Epidural Spinal Cord Stimulation
- Keywords
- spinal cord stimulation, epidural stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Spinal Cord StimulationDevice
Stimulation of the spinal cord from the epidural space.
| Study group | Role | What they receive |
|---|---|---|
| Volitional EMG power | Experimental | Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation. Receives: Device: Epidural Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Volitional electromyography (EMG) power
The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation
Measured: 10 years
Secondary outcomes (1)
Prediction of power preferences
Prediction of power of preference models built based on evaluations of stimulation settings.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start11 May 2023
- Primary completion1 Apr 2033 (estimated)
- Study completion1 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Darrow, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705453
- Sponsor's protocol ID
- IRB-FY2022-365
- Acronym
- LTO
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
- ClinicalTrials.gov ID
- NCT05705453
- Acronym / sponsor ID
- LTO / IRB-FY2022-365
- Conditions
- SCI - Spinal Cord Injury
- Keywords
- spinal cord stimulation, epidural stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 1 Apr 2033 (estimated)
- Study completion
- 1 Apr 2034 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.
Detailed description
Participants will be enrolled in this study for the duration of 10 years. They will need to come to Minneapolis twice a year for the Brain Motor Control Assessment and will be given different settings within their Spinal Cord Stimulator (SCS) programing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volitional EMG power | Experimental | Device: Epidural Spinal Cord StimulationAssessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 22 years of age or older
- Able to undergo the informed consent process
- Stable spinal cord injury
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
- No ventilator dependency within the last year
Key exclusion criteria (7 listed)
- Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
- Use of botulinum toxin (Botox) injections in the previous six months
- Clinically significant mental illness in the judgment of the principal investigator
- Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
- Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Spinal Cord StimulationStimulation of the spinal cord from the epidural space. | Device | Volitional EMG power |
Primary outcome
Change in Volitional electromyography (EMG) power
Time frame: 10 years
The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation
1 secondary outcome
Prediction of power preferences
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Clinical Trial WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Darrow, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Spinal Cord Stimulation in people with SCI - Spinal Cord Injury, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (612-873-9113, estand@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Volitional electromyography (EMG) power (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.