Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT05111093
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Must provide and sign the Informed Consent prior to any study related procedures
* Spinal cord injury lesion level between C3 and T6 (inclusive)
* SCI ≥ 1month
* Confirmed orthostatic hypotension
* Stable medical, physical and psychological condition as considered by the investigators
* Able to understand and interact with the study team in French or English
* Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments
Exclusion Criteria:
* SCI related to a neurodegenerative disease
* Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
* The inability to withhold antiplatelet/anticoagulation agents perioperatively
* History of myocardial infarction or cerebrovascular event within the past 6 months
* Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
* Clinically significant mental illness in the judgement of the investigators
* Botulinum toxin vesical and non-vesical injections in the previous 3 months before the enrolment
* Presence of significant pressure ulcers
* Recurrent urinary tract infection refractory to antibiotics
* Presence of indwelling baclofen or insulin pump
* Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding,
* Lack of safe contraception for women of childbearing capacity,
* Intention to become pregnant during the course of the study,
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrolment of the investigator, his/her family members, employees, and other dependent persons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05111093
Study Brief:
Protocol Section:
NCT05111093