Clinical trial NCT05852379: Transcutaneous Auricular Vagus Nerve Stimulation in Spinal Cord Injury
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Nervous System Diseases
Trauma, Nervous System
Movement Disorders
Central Nervous System Diseases
Keywords: gait
Vagus Nerve Stimulation
Lead sponsor: Possover International Medical Center AG
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blinded, parallel assignment
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of traumatic complete/incomplete apar/teraplgia
* At least 12 months post-traumatic SCI
* Patient included in rehabilitation program
* After laparoscopic implantation of neurosprothesis to the pelvic nerves (LION procedure)
* Mini-mental State examination score\>24
* Stable medication
* Patient who voluntarily accept the test and sign an informed consent form

Exclusion Criteria:

* There is a clear history of cerebrovascular stroke, and there are clear symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left on neuroimaging
* Patients with significant visual impairment or coexisting local or systemic diseases (eg osteoarthritis, or neuro,ogical conditions) likely to affect gait are excluded from the study
* Pathologies of the articulation and ligaments of the LE that make standing/walking anatomically impossible
* Patients who underwent deep brain stimulation surgery or those with an implanted cardiac pacemaker are excluded
* Those with history of alcoholism, or drug addiction, or neurological diseases that can cause cognitive impairment, such as brain injury, epilepsy, encephalitis, normal intracranial pressure hydrocephalus
* Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency)
* Suffering from cardiac conductive dysfunctions or sleep apnea syndrome
* Participating in other drug clinical trials
* There are contraindications to head MRI
* Those who are deemed unsuitable to participate the trial by the investigator

Primary outcomes:
measure: Evolution of the Walking Index for Spinal Cord Injury (WISCI II
timeFrame: 6 months
Secondary outcomes:
measure: ASIA Lower Extremity Motor
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Possover International Medical Center AG - Klausstrasse 4, CH-8002 Zürich
name: Marc MP Possover, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: