Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-01 @ 12:41 AM
Study NCT ID:
NCT05111093
Status:
RECRUITING
Last Update Posted:
2025-05-30
First Post:
2021-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
Sponsor:
Ecole Polytechnique Fédérale de Lausanne
Organization:
Study Overview
Official Title:
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HemON
Brief Summary:
The HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to improve hemodynamic management and trunk control in people with sub-acute or chronic spinal cord injury (\>= 1 month post injury) between C3 and T6 inclusive, who suffer from orthostatic hypotension.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: