ARC Therapy to restore hemodynamic stability and trunk control in people with spinal cord injury - HemON

ONWARD Medical0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•- 18 years of age or older
•- Must provide and sign the Informed Consent prior to any study-related
•- Traumatic spinal cord injury
•- Spinal cord injury lesion level between C3 and T6 (inclusive)
•- AIS- A, B, C or D
•- 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 Dutch or English
•- Agrees to comply in good faith with all conditions of the study and to attend
•all scheduled appointments
•- In case participants need continuous support from a personal caregiver in
•daily life, then the presence of their caregiver during the visits to the study
•site is needed, including independent transport (not dependent on a cab)

•- 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
•- 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 non-vesical and 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.

发起方

ONWARD Medical