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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active transcutaneous auricular vagus nerve stimulation | Experimental | PtaVNS, twice daily, 30 minutes each time over 6 months. Followed by 6 months home excercice program, physiotherapy twice a week, and continuous low frequency antidromic pelvic neuromodulation (CAPN). |
|
| Sham transcutaneous auricular vagus nerve stimulation | Sham Comparator | Sham PtaVNS (fictive stimulation), twice daily, 30 minutes each time over 6 months. Followed by 6 months home excercice program, physiotherapy twice a week, and continuous low frequency antidromic pelvic neuromodulation (CAPN). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active taVNS | Device | Transcutaneous auricular vague nerve stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the Walking Index for Spinal Cord Injury (WISCI II | Standardized scale that classifies the individual's walking ability in 21 levels,from 0 to 20 (Table 2), from the preoperative to the 6-month assessment. (Morganti B, Scivoletto G, Ditunno P, Ditunno JF, Molinari M. Walking index for spinal cord injury (WISCI): criterion validation. Spinal Cord 2005;43:43-71) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ASIA Lower Extremity Motor | Motor Scoring (scoring on reverse side) L2: Hip flexors L3: Knee extensors L4: Ankle dorsiflexors L5: long toe extensors S1: ankle platter flexors Scores: 0: total paralysis
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc MP Possover, MD, PhD | Contact | +41 44 520 3600 | mail@possover.com | |
| Marc Possover | Contact | +41 44 520 3601 | m.possover@possover.com |
| Name | Affiliation | Role |
|---|---|---|
| Marc MP Possover, MD, PhD | Possover International Medical Center AG - Klausstrasse 4, CH-8002 Zürich | Principal Investigator |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013118 | Spinal Cord Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Randomized, single-blinded, parallel assignment
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Triple (participants, Care provider, Outcomes Assessor)
| sham taVNS | Device | Scham transcutaneous auricular vague nerve stimulation |
|
| 6 months |