Transspinal Stimulation Plus Locomotor Training for SCI (NCT04807764) | Clinical Trial Compass
CompletedNot Applicable
Transspinal Stimulation Plus Locomotor Training for SCI
United States14 participantsStarted 2021-08-01
Plain-language summary
Locomotor training is often used with the aim to improve corticospinal function and walking ability in individuals with Spinal Cord Injury. Excitingly, the benefits of locomotor training may be augmented by noninvasive electrical stimulation of the spinal cord and enhance motor recovery at SCI. This study will compare the effects of priming locomotor training with high-frequency noninvasive thoracolumbar spinal stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests of brain and spinal cord function will be performed before and after 40 sessions of locomotor training where spinal stimulation is delivered immediately before either lying down or during standing.
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.
* Male or female, age 18-70 years old.
* In good general health as evidenced by medical history.
* Diagnosed with motor incomplete SCI (AIS 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.
* Presence of tendon reflexes to be able to elicit the soleus H-reflex.
* Absent permanent ankle joint contractures that prevent passive or active ankle movement because corticospinal and spinal excitability is based on the ankle angle. The ankle straps of the Lokomat require also 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.
* Significant neuropathies of the peripheral nervous system.
* Significant degenerative neurological disorders of the spine or spinal cord.
* AIS A or B.
* 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…
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.