Spinal Cord InjuriesNCT05730049
Neuromodulation as an Anti-inflammatory Treatment in SCI
A study testing Transcutaneous auricular vagus nerve stimulation in people with Spinal Cord Injuries and Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The goal of this single-blinded randomized, controlled trial is to assess the impact of 1-hour of active transcutaneous auricular vagus nerve stimulation (taVNS) vs sham taVNS on serum biomarkers of the inflammatory reflex and inflammation in individuals with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Inflammation
- What is being tested?
- Transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2024to 31 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any level of severity of spinal cord injury
- 18 years of age or older
Who cannot join
- pregnant or attempting to become pregnant
- people with active implants (e.g. cochlear implant, implanted vagus nerve stimulator, cardiac pacemaker)
- people with cerebral shunts
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Parkwood Institute, St Joseph's Health Care London
London, Ontario, N6C 0A7
David J Allison, PhD, 2896680656, David.Allison@sjhc.london.on.ca
About this study
Official title: Assessing the Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation as an Anti-inflammatory Treatment Following Spinal Cord Injury
The goal of this single-blinded randomized, controlled trial is to assess the impact of 1-hour of active transcutaneous auricular vagus nerve stimulation (taVNS) vs sham taVNS on serum biomarkers of the inflammatory reflex and inflammation in individuals with spinal cord injury.
The main question it aims to answer is: whether taVNS is a safe and effective anti-inflammatory intervention for individuals with SCI. Participants will perform a single 1-hour bout of the respective taVNS treatment with blood draws prior to treatment, immediately following treatment, and 24 hours following treatment. Changes in biomarkers between the active and sham taVNS conditions will be compared.
Read the detailed description
Chronic inflammation is very common among individuals living with spinal cord injury (SCI) and contributes to a number of health complications(1). Drug treatments are available to help reduce inflammation, however, many patients are unresponsive, become resistant or experience adverse effects such as increased risk of infection(2). There is a need for other treatments which reduce inflammation while avoiding harmful side effects.
It is now understood that the nervous systems plays an important role in regulating the immune system and controlling inflammation. The vagus nerve has been shown to be a particularly important part of the nervous system in terms of limiting inflammation. However, SCI causes disruption to the nervous system, including reduced activity of the vagus nerve. This may contribute to excessive inflammation. New technologies have been developed that allow the vagus nerve to be activated by electrically stimulating a part of the ear. This technique called vagus nerve stimulation (VNS) has been shown to help reduce inflammation in numerous populations. However, it has not been assessed in individuals with SCI. This study will assess if stimulating the vagus nerve can be a safe and effective way to reduce inflammation in individuals with SCI.
To assess this, 30 individuals with SCI who agree to participate will be randomly assigned to receive either active VNS treatment or sham treatment (whereby the device will placed in such a way that it does not stimulate the vagus nerve). Participants will not be aware of which group they are in. The study will take place over a 2-day period. On day one, participants will arrive in the morning for a fasted blood draw to assess baseline inflammation. Following the blood draw, participants will receive 1-hour of either the active or sham VNS therapy. Immediately following VNS therapy a second blood draw will be performed. On day 2 participants will be asked to return at the same time of day to complete a final fasted blood draw. This will allow for the assessment of how well the therapy activated 2 key anti-inflammatory pathways controlled by the vagus nerve and resulting changes in inflammation (immediate and 24-hour post).
It is expected that VNS therapy will be well-tolerated, safe and effective at reducing inflammation in individuals with SCI. If this is shown, VNS may prove to be a simple and cost-effective means of reducing chronic inflammation in individuals with SCI and may help to replace and/or reduce the need for other pharmaceutical drugs which are associated with adverse health outcomes.
- Conditions
- Spinal Cord Injuries, Inflammation
- Being tested
- Transcutaneous auricular vagus nerve stimulation
- Keywords
- Vagus Nerve Stimulation
- Medical subject headings
- Spinal Cord Injuries, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous auricular vagus nerve stimulationDevice
Also called NEMOS® taVNS device
Stimulation will target the auricular branch of the vagus nerve by applying stimulation to the cymba conchae region of the ear using the NEMOS® taVNS device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA(3). Pulse width will be set at 100μs and frequency will be set at 25Hz as performed in a previous protocol in stroke patients(3). The control group will receive the same stimulation parameters but will have the earpiece placed in the sham position such that stimulation is applied to the earlobe and does not activate the vagus nerve(4).
| Study group | Role | What they receive |
|---|---|---|
| Active taVNS | Experimental | Stimulation will target the auricular branch of the vagus nerve by applying stimulation to the cymba conchae region of the ear using the NEMOS® taVNS device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA. Pulse width will be set at 100μs and frequency will be set at 25Hz as performed in a previous protocol in stroke patients. Stimulation will be applied for a duration of 1 hour. Receives: Device: Transcutaneous auricular vagus nerve stimulation |
| Sham taVNS | Sham comparator | The control group will receive the same stimulation parameters but will have the earpiece placed in the sham position such that stimulation is applied to the earlobe and does not activate the vagus nerve. Receives: Device: Transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Biomarkers Immediately Following Intervention
Change in serum concentrations of the pro-inflammatory cytokines tumour necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1 beta (IL-1β), and interferon-gamma (IFN-y) immediately following intervention. Change in serum concentrations of acetylcholine immediately following intervention will be assessed as an indicator of the activity of the cholinergic anti-inflammatory pathway, and the change in cortisol immediately following intervention will be assessed as an indicator of the activity of the neuro-endo-immune pathway.
Measured: Baseline - Immediately Following Intervention
Change in Serum Biomarkers 24-hours Following Intervention
Change in serum concentrations of the pro-inflammatory cytokines tumour necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1 beta (IL-1β), and interferon-gamma (IFN-y) 24-hours following intervention. Change in serum concentrations of acetylcholine 24-hours following intervention will be assessed as an indicator of the activity of the cholinergic anti-inflammatory pathway, and the change in cortisol 24-hours following intervention will be assessed as an indicator of the activity of the neuro-endo-immune pathway.
Measured: Baseline - 24-hour Post Intervention
Secondary outcomes (5)
Incidence of Treatment-Emergent Adverse Events During or Immediately Following Intervention
All adverse events which occur during or immediately following the intervention will be recorded during the study visit and compared between the taVNS and sham conditions. A description of the adverse event, number of events, and total number of participants affected will be recorded.
Measured: Immediately Following Intervention
Incidence of Treatment-Emergent Adverse Events 24-hours Following Intervention
All adverse events which occur within 24-hours following the intervention will be self-reported by participants and recorded and compared between the taVNS and sham conditions. A description of the adverse event, number of events, and total number of participants affected will be recorded.
Measured: 24-hour Post intervention
Time required to recruit 30 participants
The success of participant recruitment will be assessed based on the time required to recruit the target 30 participants. Completion of recruitment in under 6-months will be considered successful.
Measured: Immediately following 6-month recruitment period
Program Completion Rates
Program completion rates will be assessed by the number of participants who completed the entire 1-hour intervention in its entirety.
Measured: Immediately after intervention
Participant Satisfaction with Intervention
Participant satisfaction with the intervention will be assessed via an 11-point visual analog scale (VAS) with scores ranging from 0-10 whereby 0 reflects complete dissatisfaction and 10 reflects complete satisfaction as well as qualitatively via participant feedback.
Measured: 24-hour Post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jan 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Eligible participants who consent to study participation will be randomized to one of two groups: active taVNS, or sham taVNS. Each group will undergo 1 hour of the respective treatment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J. Allison, PhD., Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730049
- Sponsor's protocol ID
- 12901
- Status last verified
- Apr 2024
- First submitted
- 13 Jan 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allison DJ, Ditor DS. The common inflammatory etiology of depression and cognitive impairment: a therapeutic target. J Neuroinflammation. 2014 Sep 2;11:151. doi: 10.1186/s12974-014-0151-1.
PubMed 25178630Tynan A, Brines M, Chavan SS. Control of inflammation using non-invasive neuromodulation: past, present and promise. Int Immunol. 2022 Jan 22;34(2):119-128. doi: 10.1093/intimm/dxab073.
PubMed 34558623Redgrave JN, Moore L, Oyekunle T, Ebrahim M, Falidas K, Snowdon N, Ali A, Majid A. Transcutaneous Auricular Vagus Nerve Stimulation with Concurrent Upper Limb Repetitive Task Practice for Poststroke Motor Recovery: A Pilot Study. J Stroke Cerebrovasc Dis. 2018 Jul;27(7):1998-2005. doi: 10.1016/j.jstrokecerebrovasdis.2018.02.056. Epub 2018 Mar 23.
PubMed 29580658Frangos E, Ellrich J, Komisaruk BR. Non-invasive Access to the Vagus Nerve Central Projections via Electrical Stimulation of the External Ear: fMRI Evidence in Humans. Brain Stimul. 2015 May-Jun;8(3):624-36. doi: 10.1016/j.brs.2014.11.018. Epub 2014 Dec 6.
PubMed 25573069
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation as an Anti-inflammatory Treatment Following Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05730049
- Acronym / sponsor ID
- 12901
- Conditions
- Spinal Cord Injuries, Inflammation
- Keywords
- Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 15 Feb 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.
The goal of this single-blinded randomized, controlled trial is to assess the impact of 1-hour of active transcutaneous auricular vagus nerve stimulation (taVNS) vs sham taVNS on serum biomarkers of the inflammatory reflex and inflammation in individuals with spinal cord injury.
The main question it aims to answer is: whether taVNS is a safe and effective anti-inflammatory intervention for individuals with SCI. Participants will perform a single 1-hour bout of the respective taVNS treatment with blood draws prior to treatment, immediately following treatment, and 24 hours following treatment. Changes in biomarkers between the active and sham taVNS conditions will be compared.
Detailed description
Chronic inflammation is very common among individuals living with spinal cord injury (SCI) and contributes to a number of health complications(1). Drug treatments are available to help reduce inflammation, however, many patients are unresponsive, become resistant or experience adverse effects such as increased risk of infection(2). There is a need for other treatments which reduce inflammation while avoiding harmful side effects.
It is now understood that the nervous systems plays an important role in regulating the immune system and controlling inflammation. The vagus nerve has been shown to be a particularly important part of the nervous system in terms of limiting inflammation. However, SCI causes disruption to the nervous system, including reduced activity of the vagus nerve. This may contribute to excessive inflammation. New technologies have been developed that allow the vagus nerve to be activated by electrically stimulating a part of the ear. This technique called vagus nerve stimulation (VNS) has been shown to help reduce inflammation in numerous populations. However, it has not been assessed in individuals with SCI. This study will assess if stimulating the vagus nerve can be a safe and effective way to reduce inflammation in individuals with SCI.
To assess this, 30 individuals with SCI who agree to participate will be randomly assigned to receive either active VNS treatment or sham treatment (whereby the device will placed in such a way that it does not stimulate the vagus nerve). Participants will not be aware of which group they are in. The study will take place over a 2-day period. On day one, participants will arrive in the morning for a fasted blood draw to assess baseline inflammation. Following the blood draw, participants will receive 1-hour of either the active or sham VNS therapy. Immediately following VNS therapy a second blood draw will be performed. On day 2 participants will be asked to return at the same time of day to complete a final fasted blood draw. This will allow for the assessment of how well the therapy activated 2 key anti-inflammatory pathways controlled by the vagus nerve and resulting changes in inflammation (immediate and 24-hour post).
It is expected that VNS therapy will be well-tolerated, safe and effective at reducing inflammation in individuals with SCI. If this is shown, VNS may prove to be a simple and cost-effective means of reducing chronic inflammation in individuals with SCI and may help to replace and/or reduce the need for other pharmaceutical drugs which are associated with adverse health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Eligible participants who consent to study participation will be randomized to one of two groups: active taVNS, or sham taVNS. Each group will undergo 1 hour of the respective treatment.
| Arm | Type | Receives |
|---|---|---|
| Active taVNS | Experimental | Device: Transcutaneous auricular vagus nerve stimulationStimulation will target the auricular branch of the vagus nerve by applying stimulation to the cymba conchae region of the ear using the NEMOS® taVNS device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA. Pulse width will be set at 100μs and frequency will be set at 25Hz as performed in a previous protocol in stroke patients. Stimulation will be applied for a duration of 1 hour. |
| Sham taVNS | Sham comparator | Device: Transcutaneous auricular vagus nerve stimulationThe control group will receive the same stimulation parameters but will have the earpiece placed in the sham position such that stimulation is applied to the earlobe and does not activate the vagus nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any level of severity of spinal cord injury
- 18 years of age or older
Key exclusion criteria (3 listed)
- pregnant or attempting to become pregnant
- people with active implants (e.g. cochlear implant, implanted vagus nerve stimulator, cardiac pacemaker)
- people with cerebral shunts
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 |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulationAlso: NEMOS® taVNS deviceStimulation will target the auricular branch of the vagus nerve by applying stimulation to the cymba conchae region of the ear using the NEMOS® taVNS device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA(3). Pulse width will be set at 100μs and frequency will be set at 25Hz as performed in a previous protocol in stroke patients(3). The control group will receive the same stimulation parameters but will have the earpiece placed in the sham position such that stimulation is applied to the earlobe and does not activate the vagus nerve(4). | Device | Active taVNS, Sham taVNS |
Primary outcome
Change in Serum Biomarkers Immediately Following Intervention
Time frame: Baseline - Immediately Following Intervention
Change in serum concentrations of the pro-inflammatory cytokines tumour necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1 beta (IL-1β), and interferon-gamma (IFN-y) immediately following intervention. Change in serum concentrations of acetylcholine immediately following intervention will be assessed as an indicator of the activity of the cholinergic anti-inflammatory pathway, and the change in cortisol immediately following intervention will be assessed as an indicator of the activity of the neuro-endo-immune pathway.
Change in Serum Biomarkers 24-hours Following Intervention
Time frame: Baseline - 24-hour Post Intervention
Change in serum concentrations of the pro-inflammatory cytokines tumour necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1 beta (IL-1β), and interferon-gamma (IFN-y) 24-hours following intervention. Change in serum concentrations of acetylcholine 24-hours following intervention will be assessed as an indicator of the activity of the cholinergic anti-inflammatory pathway, and the change in cortisol 24-hours following intervention will be assessed as an indicator of the activity of the neuro-endo-immune pathway.
5 secondary outcomes
Incidence of Treatment-Emergent Adverse Events During or Immediately Following Intervention
Time frame: Immediately Following Intervention
Incidence of Treatment-Emergent Adverse Events 24-hours Following Intervention
Time frame: 24-hour Post intervention
Time required to recruit 30 participants
Time frame: Immediately following 6-month recruitment period
Program Completion Rates
Time frame: Immediately after intervention
Participant Satisfaction with Intervention
Time frame: 24-hour Post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Background: PubMed 25178630Allison DJ, Ditor DS. The common inflammatory etiology of depression and cognitive impairment: a therapeutic target. J Neuroinflammation. 2014 Sep 2;11:151. doi: 10.1186/s12974-014-0151-1.
- Background: PubMed 34558623Tynan A, Brines M, Chavan SS. Control of inflammation using non-invasive neuromodulation: past, present and promise. Int Immunol. 2022 Jan 22;34(2):119-128. doi: 10.1093/intimm/dxab073.
- Background: PubMed 29580658Redgrave JN, Moore L, Oyekunle T, Ebrahim M, Falidas K, Snowdon N, Ali A, Majid A. Transcutaneous Auricular Vagus Nerve Stimulation with Concurrent Upper Limb Repetitive Task Practice for Poststroke Motor Recovery: A Pilot Study. J Stroke Cerebrovasc Dis. 2018 Jul;27(7):1998-2005. doi: 10.1016/j.jstrokecerebrovasdis.2018.02.056. Epub 2018 Mar 23.
- Background: PubMed 25573069Frangos E, Ellrich J, Komisaruk BR. Non-invasive Access to the Vagus Nerve Central Projections via Electrical Stimulation of the External Ear: fMRI Evidence in Humans. Brain Stimul. 2015 May-Jun;8(3):624-36. doi: 10.1016/j.brs.2014.11.018. Epub 2014 Dec 6.
- 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.
David J. Allison, PhD. principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous auricular vagus nerve stimulation in people with Spinal Cord Injuries and Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 2 inclusion and 3 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 David J Allison, PhD. (519 646 6100, David.Allison@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Biomarkers Immediately Following Intervention (time frame: Baseline - Immediately Following Intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05730049, which also lists 4 linked publications.
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 29 Apr 2024.