search
Back to results

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

Primary Purpose

Spinal Cord Injuries, Spinal Cord Diseases, Nervous System Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active taVNS
sham taVNS
Sponsored by
Possover International Medical Center AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring gait, Vagus Nerve Stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Active transcutaneous auricular vagus nerve stimulation

    Sham transcutaneous auricular vagus nerve stimulation

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    May 1, 2023
    Last Updated
    May 15, 2023
    Sponsor
    Possover International Medical Center AG
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05852379
    Brief Title
    Transcutaneous Auricular Vagus Nerve Stimulation in Spinal Cord Injury
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    January 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Possover International Medical Center AG

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries, Spinal Cord Diseases, Nervous System Diseases, Trauma, Nervous System, Movement Disorders, Central Nervous System Diseases
    Keywords
    gait, Vagus Nerve Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, single-blinded, parallel assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Triple (participants, Care provider, Outcomes Assessor)
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active transcutaneous auricular vagus nerve stimulation
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Sham transcutaneous auricular vagus nerve stimulation
    Arm Type
    Sham Comparator
    Arm Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    active taVNS
    Intervention Description
    Transcutaneous auricular vague nerve stimulation
    Intervention Type
    Device
    Intervention Name(s)
    sham taVNS
    Intervention Description
    Scham transcutaneous auricular vague nerve stimulation
    Primary Outcome Measure Information:
    Title
    Evolution of the Walking Index for Spinal Cord Injury (WISCI II
    Description
    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)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    ASIA Lower Extremity Motor
    Description
    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
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marc MP Possover, MD, PhD
    Phone
    +41 44 520 3600
    Email
    mail@possover.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marc Possover
    Phone
    +41 44 520 3601
    Email
    m.possover@possover.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marc MP Possover, MD, PhD
    Organizational Affiliation
    Possover International Medical Center AG - Klausstrasse 4, CH-8002 Zürich
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Transcutaneous Auricular Vagus Nerve Stimulation in Spinal Cord Injury

    We'll reach out to this number within 24 hrs