Using non-invasive spinal stimulation to improve recovery after spinal cord injury
Official title: Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury
Run by The Methodist Hospital Research Institute · NCT06213012 · Data updated 2026-11-12
This study is testing two non-invasive spinal stimulation methods to see if they can help people with spinal cord injuries recover their ability to stand and move better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | December 6, 2023 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT06213012 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males and females aged 22-60 with stable medical conditions who can tolerate upright positioning and demonstrate specific physical capabilities.
✕Probably not a fit
Patients with severe comorbidities or those unable to comply with study procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of two spinal neuromodulation techniques, transcutaneous spinal stimulation (TSS) and epidural spinal stimulation (ESS), on functional recovery in individuals with spinal cord injuries (SCI). It aims to identify the distinct electrophysiological mechanisms of each approach and how they contribute to maintaining self-assisted standing after paralysis. Participants will undergo both TSS and ESS to compare their effectiveness in promoting motor function and mobility. The study seeks to provide a cost-effective alternative to traditional invasive spinal stimulation methods.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility and independence for individuals with spinal cord injuries.
How similar studies have gone: Previous studies have shown promise with similar neuromodulation approaches, but this specific comparison of TSS and ESS is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Houston Methodist Hospital
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Dimitry Sayenko, MD, PhD — The Methodist Hospital Research Institute
- Study coordinator: Jenny Dinh, BS
- Email: jtdinh@houstonmethodist.org
- Phone: 585-507-1706
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Improving pelvic rehabilitation after spinal cord injury with epidural stimulation
This study is testing if using a special device to stimulate the spinal cord can help people with spinal cord injuries improve their bladder and bowel function through pelvic rehabilitation.
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Transcutaneous spinal cord stimulation with 4-aminopyridine and intensive rehab for chronic spinal cord injury
This pilot study tests whether combining noninvasive spinal stimulation, dalfampridine, and rigorous rehab is safe and feasible for adults with chronic spinal cord injury and whether it can help improve movement and walking.
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This study tests whether adding ZEPU-AI robotic training to usual therapy is safe and helps adults with arm or leg movement problems from stroke, spinal cord injury, brain injury, or orthopedic conditions.
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ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in Rehab
This pilot trial tests whether adding the ZEPU-AI3 robotic leg training with real-time feedback to standard rehab helps adults with lower limb motor problems from stroke, spinal cord injury, or similar conditions.
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Combined magnetic stimulation and ultrasound for detrusor overactivity in spinal cord injury
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.