Transcutaneous Auricular Vagus Nerve Stimulation in Spinal Cord Injury

NCT05852379 | Unknown DMC

• 1 other identifier: Possover International Medical
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases; Nervous System Diseases; Trauma, Nervous System; Movement Disorders; Central Nervous System Diseases

Keywords

gait; Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ASIA Lower Extremity Motor

  6 months

Study Arms (2)

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).

Device: active taVNS

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).

Device: sham taVNS

Interventions

active taVNS DEVICE

Transcutaneous auricular vague nerve stimulation

Active transcutaneous auricular vagus nerve stimulation

sham taVNS DEVICE

Scham transcutaneous auricular vague nerve stimulation

Sham transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Possover International Medical Center AG: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases; Nervous System Diseases; Trauma, Nervous System; Movement Disorders; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Marc MP Possover, MD, PhD

  Possover International Medical Center AG - Klausstrasse 4, CH-8002 Zürich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc MP Possover, MD, PhD

CONTACT

+41 44 520 3600; mail@possover.com

Marc Possover

CONTACT

+41 44 520 3601; m.possover@possover.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple (participants, Care provider, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, single-blinded, parallel assignment

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 10, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share