ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury

NCT05941819 | Unknown DMC

• 1 other identifier: HemON2022_NL
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury; Orthostatic Hypotension

Outcome Measures

Primary Outcomes (1)

• Occurence of Serious Adverse Event and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Thoracic System

  Assess the safety of ARC-IM Therapy at supporting the management of hemodynamic instability with sub-acute or chronic spinal cord injury suffering from orthostatic hypotension

  Throughout study, average of 15.5 months

Study Arms (1)

All participants

EXPERIMENTAL

All participants will be provided with the ARC-IM Thoracic System (implantable and non-implantable parts)

Device: ARC-IM Thoracic System implantation

Interventions

ARC-IM Thoracic System implantation DEVICE

Implantation of the ARC-IM Thoracic Lead on the low thoracic level of the spinal cord and implantation of the ARC-IM IPG in the abdominal region

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• ONWARD Medical, Inc.: lead

Study Sites (1)

Sint Maartenskliniek

Ubbergen, 6574NA, Netherlands

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ilse Van Nes, MD, PhD

  Sint Maartenskliniek, department of rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: September 5, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

NL (1)