ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury (HemON-NL)

ONWARD Medical

Status

Enrolling

Conditions

Spinal Cord Injury

Orthostatic Hypotension

Treatments

Device: ARC-IM Thoracic System implantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT05941819

HemON2022_NL

Details and patient eligibility

About

The goal of this interventional study is to evaluate the safety and preliminary effectiveness of the ARC-IM Therapy to improve hemodynamic management in people with sub-acute or chronic spinal cord injury.

Participants will be implanted with the ARC-IM Thoracic System which aim to deliver, at the low thoracic level, targeted epidural electrical stimulation that will support natural hemodynamic control.

Enrollment

16 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Diseases and conditions that would require regular MRI
The inability to perform an MRI due to metal, magnetic or electrical device in the body (e.g. oral implant with magnet, mtal splinter, neurostimulator, artificial heart valve, clips, stents...) as assessed by the MRI form of Sint Maartenskliniek
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 (e.g. intrathecal baclofen pump) 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