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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

- 18 years of age or older
- Must provide and sign the Informed Consent prior to any study-related
procedures
- 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)

Exclusion Criteria

- 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 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the study is the occurrence of serious adverse events<br /><br>and adverse events that are deemed related or possibly related to the study<br /><br>procedure or to the ARC-IM Thoracic System, from implantation up to the end of<br /><br>the study</p><br>

Secondary Outcome Measures