Status:
COMPLETED
Acute Effects of Pharmacological Neuromodulation on Leg Motor Activity in Patients With SCI Treated With EES
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborating Sponsors:
Ecole Polytechnique Fédérale de Lausanne
Conditions:
Spinal Cord Injuries
Drug Effect
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 ap...
Detailed Description
The aim is to test the effects of orally administered buspirone and levodopa/carbidopa taken individually and in combination. Both buspirone and levodopa can cross the blood-brain barrier, and reach t...
Eligibility Criteria
Inclusion
- 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
- 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-dopamine reuptake inhibitors (NDRIs)
- Monoamine oxidase inhibitors (MAOIs)
- Patients who are receiving treatments altering the noradrenergic and dopaminergic transmission (e.g., bupropion and levodopa/carbidopa)
- Patients who are taking narcotic pain killers (e.g., opioids) and neuropathic medication (e.g., gabapentin, pregabalin)
- Patients who are taking antihypertensive drugs and diuretics (e.g., furosemide or hydrochlorothiazide)
- Patients who are taking hypnotic drugs (e.g., Zolpidem).
- Patients receiving D2 antagonists or antipsychotic drugs (e.g., butyrophenone, phenothiazines, risperidone)
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
Key Trial Info
Start Date :
September 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04052776
Start Date
September 11 2020
End Date
October 4 2023
Last Update
October 5 2023
Active Locations (1)
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1
CHUV
Lausanne, Canton of Vaud, Switzerland, 1011