Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852379
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-17
First Post:
2023-05-01
Brief Title:
Transcutaneous Auricular Vagus Nerve Stimulation in Spinal Cord Injury
Sponsor:
Possover International Medical Center AG
Organization:
Possover International Medical Center AG
Study Overview
Official Title:
Transcutaneous Auricular Vagus Nerve Stimulation Paired With Rehabilitation and Pelvic Nerves Stimulation for Improvement Motor Functions of Lower Extremities in Peoples With Chronic Spinal Cord Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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:
taVNS
Brief Summary:
This study is a single blinded prospective randomized monocentric study examining the effectiveness of transcutaneous auricular vagus nerve stimulation paired with rehabilitation and low frequencyantidromic stimulation of the pelvic somatic nerves The investigator hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve gait recovery in spinal cord injured participants already treating by rehabilitation and pelvic nerves neuromodulation
Detailed Description:
In this single-blinded prospective randomized study 10 participants adults above 18years with chronic spinal cord injury already managed with active rehabilitation and continuous pelvic nerves stimulation low-frequency antidormic will be randomly assigned in a 11 ratio to active taVNS twice daily 30 minutes each time or control with daily sessions of sham taVNS 00 mA Rehabilitation is performed unspecifically by home-rehabilitations team or physiotherapeutists with exercises adjusted to the participants functional level This protocol comprised 15 to 20 weekly hours of multidisciplinary care including neurofunctional physiotherapy and aquatic therapy cardiorespiratory physiotherapy two hoursweek All participants have undergone previously an implantation of a stimulator for chronic neuromodulation of the pelvic somatic nerves according with the LION procedure Participants and therapeutists will maintain blinding until the completion of the study 6 months Assessment of gait function motor symptoms are performed three time at baseline at 3-months follow up and at 6months follow up
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None