Trials / Unknown
UnknownNCT05852379
Transcutaneous Auricular Vagus Nerve Stimulation in Spinal Cord Injury
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
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Possover International Medical Center AG · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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 frequency/antidromic 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 1:1 ratio to active taVNS (twice daily, 30 minutes each time), or control with daily sessions of sham taVNS (0.0 mA). Rehabilitation is performed unspecifically by home-rehabilitation's team or physiotherapeutists with exercises adjusted to the participant's functional level. This protocol comprised 15 to 20 weekly hours of multidisciplinary care, including neurofunctional physiotherapy and aquatic therapy, cardiorespiratory physiotherapy (two hours/week). 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.
Conditions
- Spinal Cord Injuries
- Spinal Cord Diseases
- Nervous System Diseases
- Trauma, Nervous System
- Movement Disorders
- Central Nervous System Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | active taVNS | Transcutaneous auricular vague nerve stimulation |
| DEVICE | sham taVNS | Scham transcutaneous auricular vague nerve stimulation |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2023-12-31
- Completion
- 2024-01-31
- First posted
- 2023-05-10
- Last updated
- 2023-05-17
Source: ClinicalTrials.gov record NCT05852379. Inclusion in this directory is not an endorsement.