Trials / Recruiting
RecruitingNCT05111093
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Ecole Polytechnique Fédérale de Lausanne · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ARC-IM Investigational System implantation | Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region. |
Timeline
- Start date
- 2021-11-29
- Primary completion
- 2030-12-31
- Completion
- 2030-12-31
- First posted
- 2021-11-08
- Last updated
- 2025-05-30
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT05111093. Inclusion in this directory is not an endorsement.