Transcutaneous Auricular Vagus Nerve Stimulation in Spinal Cord Injury

Not Applicable

Not yet recruiting

• Conditions: Spinal Cord Diseases; Nervous System Diseases; Spinal Cord Injuries; Trauma, Nervous System; Movement Disorders; Central Nervous System Diseases
• Interventions: Device: sham taVNS; Device: active taVNS

• Registration Number: NCT05852379
• Lead Sponsor: Possover International Medical Center AG

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-01
• Study First Posted: 2023-05-10
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17
• Study Start: 2023-07-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham transcutaneous auricular vagus nerve stimulation	sham taVNS	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).
Active transcutaneous auricular vagus nerve stimulation	active taVNS	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).

Primary Outcome Measures

Name	Time	Method
Evolution of the Walking Index for Spinal Cord Injury (WISCI II	6 months	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)

Secondary Outcome Measures

Name	Time	Method
ASIA Lower Extremity Motor	6 months	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; 1. palpable or visible contraction; 2. active movement, gravity eliminated; 3. active movement, against gravity; 4. active movement; against some resistance; 5. active movement, against full resistance