Transcutaneous Auricular Vagus Nerve Stimulation in Spinal Cord Injury (taVNS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Intervention / Treatment: Device: active taVNS; Device: sham taVNS

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc MP Possover, MD, PhD; Phone Number: +41 44 520 3600; Email: mail@possover.com
• Study Contact Backup: Name: Marc Possover; Phone Number: +41 44 520 3601; Email: m.possover@possover.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active transcutaneous auricular vagus nerve stimulation; 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).	Device: active taVNS; Transcutaneous auricular vague nerve stimulation
Sham Comparator: Sham transcutaneous auricular vagus nerve stimulation; 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).	Device: sham taVNS; Scham transcutaneous auricular vague nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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; palpable or visible contraction; active movement, gravity eliminated; active movement, against gravity; active movement; against some resistance; active movement, against full resistance	6 months

Collaborators and Investigators

• Sponsor: Possover International Medical Center AG
• Investigators: Principal Investigator: Marc MP Possover, MD, PhD, Possover International Medical Center AG - Klausstrasse 4, CH-8002 Zürich

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: gait; Vagus Nerve Stimulation
• Additional Relevant MeSH Terms: Wounds and Injuries; Nervous System Diseases; Spinal Cord Diseases; Spinal Cord Injuries; Movement Disorders; Trauma, Nervous System; Central Nervous System Diseases
• Other Study ID Numbers: Possover International Medical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No