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

• Sponsor: ONWARD Medical, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05941819
• Collaborator: (none)
• Enrollment: 16
• Arm: 1
• Anticipated Duration (Months): 26.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury; Orthostatic Hypotension	Device: ARC-IM Thoracic System implantation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
• Anticipated Study Start Date: Jul 15, 2023
• Anticipated Primary Completion Date: Sep 30, 2025
• Anticipated Study Completion Date: Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All participants All participants will be provided with the ARC-IM Thoracic System (implantable and non-implantable parts)	Device: ARC-IM Thoracic System implantation; 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

Outcome Measures

Primary Outcome Measures

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 [Throughout study, average of 15.5 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ONWARD Medical, Inc.

Investigators

• Principal Investigator: Ilse Van Nes, MD, PhD, Sint Maartenskliniek, department of rehabilitation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ONWARD Medical, Inc.
• ClinicalTrials.gov Identifier: NCT05941819
• Other Study ID Numbers: HemON2022_NL
• First Posted: Jul 12, 2023
• Last Update Posted: Jul 12, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spinal Cord Injuries; Hypotension, Orthostatic; Hypotension; Wounds and Injuries

Study Results

No Results Posted as of Jul 12, 2023