Spinal stimulation showdown: which technique helps paralyzed patients stand?
NCT ID NCT06213012
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of spinal stimulation—transcutaneous (through the skin) and epidural (implanted via surgery)—to see how they help people with spinal cord injury generate leg force and stand with support. Sixty adults aged 22-75 who cannot stand independently will participate. The goal is to understand the brain and spinal cord changes behind any recovery, not to test a cure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transcutaneous spinal cord stimulation and epidural spinal stimulation
- What this could lead to
- If successful, this could clarify which stimulation method best helps people with spinal cord injury regain standing ability, guiding future treatments.
- What could go wrong
- This is an early-stage, small study (60 participants) focused on understanding mechanisms, not proving a treatment works. The epidural group requires surgery, which carries risks like infection or device complications.
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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Aug 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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22 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.
Inclusion criteria 1. All participants must be able to provide a provision of a signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged 22-75 years old. 4. Documentation from the participant's primary treating physician confirming a stable medical condition. 5. Inability to maintain standing independently without external support due to SCI AIS A-C. 6. Ability to tolerate at least 15 minutes in an upright (supported) position. 7. Able to self-transfer from the wheelchair and demonstrate active range of motion of bilateral upper extremities in gravity dependent plane. 8. Able to passively range bilateral lower extremities within normal mobility parameters including: 1. greater than 90 degrees of hip flexion and 165 degrees of hip extension; 2. greater than 90 degrees of knee flexion and reach neutral knee extension of 180 degrees; 3. neutral ankle position reaching a minimum of 90 degrees of dorsiflexion. 9. Participants should be on a stable intrathecal baclofen or oral anti-spasticity regimen/dose for the period of the study unless advised otherwise by their physician. 10. 1 to 30 years post spinal cord injury. 11. Non-progressive spinal cord injury. 12. Neurological level of injury below C4 and above T12 (excluding conus injury and/or indications of lower motor neuron injury). 13. Eligible for fMRI per safety questionnaire. 14. Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study. 15. Able to commit to the full study. Exclusion Criteria: 1. Ability to maintain standing independently without external support. 2. Currently involved in another rehabilitation training of the lower extremities. 3. Active pressure sores, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including but not limited to contractures in the upper and lower extremities). 4. Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active urinary tract infections, pregnant or nursing). 5. Intrathecal baclofen pump therapy for spasticity not compatible with 3T MRI. 6. Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months, resulting in absence of muscle tone and precluding response to electrical stimulation therapy. 7. Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities). 8. Clinically significant depression, psychiatric disorders, or ongoing drug abuse, including heavy alcohol use. 9. Any reason the PI or treating physician may deem as harmful to the participant to enroll or continue in the study. 10. Body Mass Index (BMI) over 30. 11. Pregnancy. 12. Use a ventilator or diaphragmatic pacer. 13. Participants with the following conditions will be excluded from TMS, but may take part in the overall study: * Personal or first-degree family history of seizures or epilepsy. * Metal in the head, except mouth implants. * History of suicide attempts. * History of intracranial lesions, increased intracranial pressure, or stroke. * Current use of tricyclic anti-depressants, selective serotonin reuptake inhibitors (SSRIs), serotonin nor-epinephrine reuptake inhibitors (SNRIs), buproprion (Wellbutrin), or tramadol.
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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
1 site. 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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Houston Methodist Hospital
RECRUITINGHouston, Texas, 77030, United States
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- Zapping the spine: a new hope for kids with paralysis?