Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury (NCT07204184) | Clinical Trial Compass
RecruitingNot Applicable
Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury
United States36 participantsStarted 2026-02-19
Plain-language summary
A well-established rehabilitation strategy for improvements of standing and walking ability in persons with spinal cord injury (SCI) is step training on a motorized treadmill with body weight support. A promising intervention is stimulation of the spinal cord through the skin (transspinal). No single intervention is likely to significantly improve long-term function after SCI on its own. Rather, combinatorial treatments that work synergistically and can be used at different clinical settings is the answer to target recovery in people with SCI. The objective of this clinical trial is to develop a non-invasive combinatorial intervention that can be used worldwide in different clinical settings. The investigators will use cervical and lumbosacral transspinal stimulation to augment the benefits of locomotor training and affect vital body functions after SCI. The investigators will deliver non-invasive cervical and lumbosacral transspinal stimulation alone or with step training to improve upright posture, walking, bladder, sex, and bowel function in persons with incomplete SCI. The noninvasive nature of the intervention holds minimal risk that outweighs the benefits.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willingness to comply with all study procedures and availability for the duration of the study.
* Ability to understand the consent form and sign the consent form.
* In good general health as evidenced by medical history.
* Diagnosed with incomplete SCI (AIS B, C, D).
* Bone mineral density of the hip (proximal femur) T-score \<3.5 SD from age- and gender-matched normative data.
* Lesion above thoracic (T) 10 to ensure absent lower motoneuron lesion.
* The presence of soleus and FCR H-reflexes.
* Absent permanent ankle joint contractures prevent passive or active ankle movement because corticospinal and spinal excitability is based on the ankle angle. The ankle straps of the Lokomat also require flexible ankle joints.
* A diagnosis of first time SCI due to trauma, vascular, or orthopedic pathology.
* Time after SCI of more than 6 months.
* Stable medical condition without cardiopulmonary disease or cognitive impairment.
Exclusion Criteria:
* Supraspinal lesions.
* Neuropathies of the peripheral nervous system.
* Significant degenerative neurological disorders of the spine or spinal cord.
* Diagnosed with AIS A.
* Presence of pressure sores.
* Advanced urinary tract infection.
* Neoplastic or vascular disorders of the spine or spinal cord.
* Participation in an ongoing research study or new rehabilitation program.
* Pregnant women or women who suspect they may be or may become pregnant will be excluded from participation because the risks of thoracolum…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Soleus H-reflex recruitment curve
Timeframe: Before and 1 day after all intervention sessions are completed.
2
Soleus H-reflex rate-dependent depression
Timeframe: Before and 1 day after all intervention sessions are completed.
3
Soleus H-reflex phase-dependent modulation during stepping
Timeframe: Before and 1 day after all intervention sessions are completed.
4
Leg transspinal evoked potentials recruitment curves
Timeframe: Before and 1 day after all intervention sessions are completed.
5
Flexor carpus radialis H-reflex recruitment curve
Timeframe: Before and 2 days after all intervention sessions are completed.