Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury (HemON)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05111093|
Recruitment Status : Recruiting
First Posted : November 8, 2021
Last Update Posted : October 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: ARC-IM Investigational System implantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury|
|Actual Study Start Date :||November 29, 2021|
|Estimated Primary Completion Date :||July 31, 2024|
|Estimated Study Completion Date :||July 31, 2024|
Experimental: all participants
All participants will be provided with the ARC-IM Investigational System (implantable and non-implantable parts)
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.
- Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Investigational System [ Time Frame: Throughout study, an average of 26 months ]Evaluate the safety of ARC-IM Therapy at supporting management of hemodynamic instability in participants with sub-acute or chronic spinal cord injury suffering from orthostatic hypotension
- Orthostatic head-up tilt test (hemodynamic stability assessment) [ Time Frame: Baseline ; at 1 - 6.5 - 13 - 19.5 - 26 months after the implantation ]Participant begin by resting in the supine position during which baseline measures are performed. Thereafter, participant is passively moved to upright position using a tilt-table and kept in this position for a maximum of 10 minutes. This test will be performed with and without ARC-IM Therapy. Beat by beat blood pressure is monitored and catecholamine concentrations in the plasma are measured during the tilt-test.
- Trunk stability measurement (trunk control assessment) [ Time Frame: Baseline ; at 1 - 6.5 - 13 - 19.5 - 26 months after the implantation ]The participant is asked to perform a systematic set of reaching movements, balance and posture tasks while seated freely (without a back-rest). Each task is repeated and pressure, force, kinetic and kinematic data is recorded together with video acquisitions.
- Modified Ashworth Scale (MAS) (spasticity assessment) [ Time Frame: Baseline ; at 1 - 6.5 - 13 - 19.5 - 26 months after the implantation ]
Participants' upper and lower limb spasticity levels (6 points nominal scale) are assessed by rating the resistance of a muscle to a passive range of motion about a single joint. This test will be performed with and without ARC-IM Therapy.
Scores range from 0 to 5 (0, 1, 1+, 2, 3, 4, 5) with higher scores indicating higher spasticity.
- SCIM III (daily life performance assessment) [ Time Frame: Baseline ; at 1 - 6.5 - 13 - 19.5 - 26 months after the implantation ]The Spinal Cord Independence Measure (SCIM) is a disability score to assess functional activity in participants. Function is assessed in 3 areas of function: self-care (0-20), respiration and sphincter management (0-40) and mobility (0-40). Total score ranges between 0-100, with higher scores reflecting greater functional ability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05111093
|Contact: Gregoire Courtine, Prof||+41 21 69 email@example.com|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: Jocelyne Dr Bloch, Prof. Dr.|
|Principal Investigator:||Jocelyne Bloch, MD||CHUV|