Acute Effects of Pharmacological Neuromodulation on Leg Motor Activity in Patients With SCI Treat… (NCT04052776) | Clinical Trial Compass
CompletedPhase 1
Acute Effects of Pharmacological Neuromodulation on Leg Motor Activity in Patients With SCI Treated With EES
Switzerland3 participantsStarted 2020-09-11
Plain-language summary
In a current first-in-man study, called Stimulation Movement Overground (STIMO) (NCT02936453; CER-VD: 04-2014; Swissmedic: 2016-MD-0002), epidural electrical stimulation (EES) of the spinal cord is applied to enable individuals with severe spinal cord injury (SCI) to complete intensive locomotor neurorehabilitation training. In this clinical feasibility study, it was demonstrated that EES results in an immediate enhancement of locomotor functions and that when applied repeatedly as part of a neurorehabilitation program, EES can progressively improve leg motor control in individuals with severe SCI. Mechanistically, EES acts trans-synaptically upon spinal circuitries through the electrical stimulation of proprioceptive fibers.
It is assumed that this stimulation does not increase the level of availability of monoamine neurotransmitters below the SCI level, which are essential for lower extremity movement generation. Specifically, in a non-injured individual, dopamine and serotonin synthesized in the brain and brainstem are released by fibers diffusely innervating the spinal cord, serving to critically mediate excitability of motor neurons and interneurons in lumbar and sacral spinal level. Spinal cord injury would partially or entirely disrupt these modulation pathways, resulting in a detrimental lack of crucial neurotransmitters below the injury level. This lack of endogenous neurotransmitters could potentially be compensated for by pharmacological agents promoting the neurochemical environment necessary for locomotion.
Who can participate
Age range
18 Years – 65 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:
* Completed the main phase of the STIMO study
* Enrolled in the STIMO study extension
* Age 18-65 (women or men)
* Sensorimotor or motor complete and incomplete SCI graded as AIS A, B, C \& D
* Stable medical, physical and psychological condition as considered by Investigators
* Able to understand and interact with the study team in French or English
* Adequate caregiver support and access to appropriate medical care in the patient's home community
* Agree to comply with all conditions of the study and to attend all required study training and visit
* Must provide and sign Informed Consent prior to any study-related procedures
Exclusion Criteria:
* Epilepsy
* Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breastfeeding or not willing to take contraception.
* Known or suspected non-compliance, drug or alcohol abuse.
* Gastrointestinal ulcers in the last five years
* Known or suspected eye disorders or diseases
* Known or suspected allergies or hypersensitivity to buspirone, levodopa or carbidopa.
* Taking selective and non-selective serotonin reuptake inhibitors or any other treatments acting upon serotonergic transmission, such as the following:
* Selective serotonin reuptake inhibitors (SSRIs)
* Serotonin-norepinephrine reuptake inhibitors (SNRIs)
* Serotonin antagonists and reuptake inhibitors (SARIs)
* Tricyclic antidepressants (TCAs)
* Tetracyclic antidepressants (TeCAs)
* Norepinephrine-dopami…
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
Rate of AEs/SAEs/Side effects
Timeframe: Changes from baseline condition over a treatment session of 4 hours
2
Changes in blood pressure
Timeframe: Changes from baseline condition over a treatment session of 4 hours
3
Changes in heart rate
Timeframe: Changes from baseline condition over a treatment session of 4 hours