Spinal Cord Injury Clinical Trial
— HemON-NLOfficial title:
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
Verified date | October 2023 |
Source | ONWARD Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 16 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Sint Maartenskliniek | Ubbergen |
Lead Sponsor | Collaborator |
---|---|
ONWARD Medical, Inc. |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02574572 -
Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
|
Phase 1 | |
Completed |
NCT05265377 -
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
|
N/A | |
Recruiting |
NCT02331979 -
Improving Bladder Function in SCI by Neuromodulation
|
N/A | |
Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
Recruiting |
NCT02978638 -
Electrical Stimulation for Continence After Spinal Cord Injury
|
N/A | |
Completed |
NCT02161913 -
Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
|
N/A | |
Withdrawn |
NCT02237547 -
Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT02262234 -
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
|
Phase 1/Phase 2 | |
Terminated |
NCT02080039 -
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
|
N/A | |
Completed |
NCT01642901 -
Zoledronic Acid in Acute Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT01884662 -
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
|
N/A | |
Completed |
NCT01471613 -
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
|
Phase 1/Phase 2 | |
Terminated |
NCT01433159 -
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
|
Phase 2 | |
Completed |
NCT02149511 -
Longitudinal Morphometric Changes Following SCI
|
||
Completed |
NCT01467817 -
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|
N/A | |
Completed |
NCT01086930 -
Early Intensive Hand Rehabilitation After Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT01025609 -
Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
|
||
Completed |
NCT00663663 -
Telephone Intervention for Pain Study (TIPS)
|
N/A | |
Terminated |
NCT01005615 -
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT00860951 -
P300 Brain Computer Interface Keyboard to Operate Assistive Technology
|
Phase 1/Phase 2 |