Transcutaneous Auricular Vagus Nerve Stimulation in Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

— taVNS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05852379
• Other study ID #: Possover International Medical
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: May 2023
• Source: Possover International Medical Center AG
• Contact: Marc MP Possover, MD, PhD
• Phone: +41 44 520 3600
• Email: mail[@]possover.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Movement Disorders
• Nervous System Diseases
• Spinal Cord Diseases
• Spinal Cord Injuries
• Trauma, Nervous System
• Wounds and Injuries

Intervention

Device:
• active taVNS
Transcutaneous auricular vague nerve stimulation
• sham taVNS
Scham transcutaneous auricular vague nerve stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Possover International Medical Center AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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