Could a spinal implant ease pain and boost recovery after paralysis?
NCT ID NCT04894734
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether an implanted spinal cord stimulator can reduce chronic pain and improve rehabilitation outcomes in people with thoracic spinal cord injury. Twenty-five participants will either have the device turned on or off for three months, while both groups continue standard care like medication and physical therapy. After that, the placebo group can also receive stimulation. The goal is to see if the device is feasible and helpful for pain, movement, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- spinal cord stimulator (implanted device)
- What this could lead to
- If it works, this could point toward a way to reduce chronic pain and improve movement, bowel/bladder function, and quality of life after spinal cord injury.
- What could go wrong
- This is a very small, early feasibility study with only 25 people. It is not designed to prove effectiveness, and results may not apply to everyone. Surgery to implant the device carries risks like infection or device failure.
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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25 people
The number who actually took part.
- Started
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Dec 2021
- Expected to finish
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Jun 2028
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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18 to 80 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Subjects enrolled in this study must meet all of the following inclusion criteria (based on investigator judgement): 1. Traumatic, thoracic SCI 2. Chronic neuropathic pain (i.e., Pain \>3 for \> 3 months) 3. Willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires 4. 18-80 years of age 5. Medically stable enough to undergo surgical implantation of an SCS / participate in rehabilitation regimens Exclusion Criteria: Subjects enrolled in this study must not meet any of the following exclusion criteria (based on investigator judgement): 1. Complete cord transection 2. Persistent spinal instability or other injury preventing ability to participate 3. Active infection 4. Comorbid psychosis or psychotic disorder 5. Untreated, clinically significant depression 6. Active drug or alcohol abuse 7. Pregnant women or women who intend to become pregnant during the duration of the study. Women of childbearing potential need a negative pregnancy test 8. Patients without symptoms of neuropathic pain \>3/10 for \> 3 months 9. Patient deemed not medically stable for surgery
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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.
Contacts and locations
Locations
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Duke University Health Systems
Durham, North Carolina, 27710, United States