Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury (NCT06274021) | Clinical Trial Compass
RecruitingEarly Phase 1
Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury
United States16 participantsStarted 2024-03-01
Plain-language summary
People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.
The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future.
Who can participate
Age range
18 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:
* Age 18 years or older
* History of spinal cord injury
* Time since diagnosis longer than six months
* Presence of spasticity in the lower limbs (≥ 3 on the Numerical Rating Scale of Spasticity Severity \[range from 0 to 10\])
* If needed, agreement to reduce antispastic medication
Exclusion criteria:
* Neurological level of spinal cord injury below T11
* Ventilatory-dependent
* Change in neurological status over the past 2 months
* Rigidity, contraction, or passive range of motion of less than 40 deg in both knee joints
* Botulinum toxin injections in lower extremities in the previous 3 months before enrollment
* Systolic blood pressure at rest lower than 90 mm Hg
* Implanted active devices (e.g., intrathecal baclofen pumps)
* Passive implants (plates, screws) between T11 and L2 vertebras
* Skin conditions precluding placement of electrodes
* Pressure ulcers stage 2 or higher on the gluteal area or lower extremities
* Receiving antibiotics for infections
* Pregnancy
* Difficulty following instructions
* Participation in another study with investigational drugs or devices within the 30 days preceding and during the present study
* Other medical risks/contraindications as determined by the study physicians
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
Change from baseline of posterior root reflexes (PRRs) recruitment curves.
Timeframe: Baseline and at post-intervention (100 minutes)
2
Change from baseline of flexion withdrawal reflex (FWR) response amplitude.
Timeframe: Baseline and at post-intervention (100 minutes)
3
Change from baseline of stretch reflex (SR) response amplitude.
Timeframe: Baseline and at post-intervention (100 minutes)
4
Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS),
Timeframe: Baseline and at post-intervention (100 minutes)
5
Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS).
Timeframe: Baseline and at post-intervention (100 minutes)