Spinal Cord InjuriestaVNSNCT05852379
Transcutaneous Auricular Vagus Nerve Stimulation in Spinal Cord Injury
A study testing active taVNS in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Possover International Medical Center AG.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases, Nervous System Diseases
- What is being tested?
- active taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Nervous System Diseases, Trauma, Nervous System, Movement Disorders, Central Nervous System Diseases
- Being tested
- active taVNS, sham taVNS
- Keywords
- gait, Vagus Nerve Stimulation
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases, Nervous System Diseases, Trauma, Nervous System, Movement Disorders, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active taVNSDevice
Transcutaneous auricular vague nerve stimulation
sham taVNSDevice
Scham transcutaneous auricular vague nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blinded, parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Possover International Medical Center AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc MP Possover, MD, PhD, Principal investigator, Possover International Medical Center AG - Klausstrasse 4, CH-8002 Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852379
- Sponsor's protocol ID
- Possover International Medical
- Acronym
- taVNS
- Status last verified
- May 2023
- First submitted
- 1 May 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05852379
- Acronym / sponsor ID
- taVNS / Possover International Medical
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Nervous System Diseases, Trauma, Nervous System, Movement Disorders, Central Nervous System Diseases
- Keywords
- gait, Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Possover International Medical Center AGUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-blinded, parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Active transcutaneous auricular vagus nerve stimulation | Experimental | Device: active taVNSPtaVNS, 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 transcutaneous auricular vagus nerve stimulation | Sham comparator | Device: sham taVNSSham 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active taVNSTranscutaneous auricular vague nerve stimulation | Device | Active transcutaneous auricular vagus nerve stimulation |
| sham taVNSScham transcutaneous auricular vague nerve stimulation | Device | Sham transcutaneous auricular vagus nerve stimulation |
Primary outcome
Evolution of the Walking Index for Spinal Cord Injury (WISCI II
Time frame: 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)
1 secondary outcome
ASIA Lower Extremity Motor
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc MP Possover, MD, PhD principal investigator
Possover International Medical Center AG - Klausstrasse 4, CH-8002 Zürich
Questions about this trial
What is this clinical trial studying?
A study testing active taVNS in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Possover International Medical Center AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc MP Possover, MD, PhD (+41 44 520 3600, mail@possover.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the Walking Index for Spinal Cord Injury (WISCI II (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.