Ischemic StrokeVANSNCT05417009
Autonomic Neuromodulation by Transcutaneous Nerve Stimulation in Acute Ischaemic Stroke.
A study testing trans-cutaneous auricular sensory stimulation in people with Ischemic Stroke and Thrombotic Stroke, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Autonomic modulation by transcutaneous vagal nerve stimulation in acute ischaemic stroke requiring mechanical thrombectomy: a phase IIa, sham controlled randomised trial. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Ischemic Stroke, Thrombotic Stroke, Autonomic Dysfunction
- What is being tested?
- trans-cutaneous auricular sensory stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2023to 21 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing mechanical thrombectomy for acute ischaemic stroke requiring general or sedation.
- Established hypertensive and/or hypertensive on admission for mechanical thrombectomy [systolic BP >140mmHg; diastolic BP >80mmHg]
Who cannot join
- Current participation in a clinical trial of a treatment with a similar biological mechanism.
- Previous enrolment into VANS trial.
- Anatomical or other contraindication to trans-cutaneous auricular sensory stimulation
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, John Vane Science Centre, Charterhouse Square
London, EC1M 6BQ
About this study
Official title: Vagal Autonomic Neuromodulation by Transcutaneous Nerve Stimulation in Acute Ischaemic Stroke Requiring Mechanical Thrombectomy.
Autonomic modulation by transcutaneous vagal nerve stimulation in acute ischaemic stroke requiring mechanical thrombectomy: a phase IIa, sham controlled randomised trial.
Read the detailed description
Loss of autonomic variability is strongly associated with adverse outcomes after ischaemic stroke. Removing blood clots from the brain by mechanical thrombectomy has revolutionised the management of stroke, but more than 50% of patients do not regain functional independence.(PMID:26898852) Blood pressure (BP) control is important, since low and high BP (BP variability) are strongly associated with poor patient outcomes after thrombectomy. (PMIDs:32961389;31964286) Autonomic dysfunction causes labile blood pressure. Intact autonomic function is required to control blood pressure and potentially improve recovery after stroke. Impairment of baroreflex autonomic function, due to reduced vagal activity is associated with extreme BP variability, leading to further brain injury and cardiovascular complications.(PMID:30371208) Reduced baroreflex control is related to poor patient outcomes after stroke, independent of absolute blood pressure.(PMID:19834010) Reversing baroreflex and vagal dysfunction is, therefore, widely held to have the potential to improve cardiovascular control and patient outcome in this context.(PMID:19834010)
Non-invasive peripheral neuromodulation restores autonomic control. Vagal nerve stimulation improves autonomic control and reverses baroreflex dysfunction (PMIDs:28949064) but this has previously required surgically implanted devices which are expensive and impractical in the context of acute stroke. Afferent Electronic have achieved the same effect as these implantable devices by non-invasive transcutaneous autonomic neuromodulation (TAN). We have used this simple, safe, hand-held, low-cost device to increase vagal activity and baroreflex sensitivity through non-invasive, painless stimulation of nerves located in the outer ear to control blood pressure.
Baroreflex sensitivity can be increased at the bedside by TAN for 30 minutes following acute trauma. If this can be replicated in thrombectomy patients, it will aid recovery and rehabilitation through five complementary mechanisms where it has been clinically demonstrated that increasing vagal nerve activity:
- Restore baroreflex sensitivity;
- Increase blood flow to ischaemic brain tissue through vagal activation.(PMID:27357059)
- Dampen cerebral/systemic inflammation.(PMID:26723020);
- Reduce atrial fibrillation and myocardial injury,(PMIDs:5744003,22739118) which are common after stroke, and independently predict cognitive decline and cardiovascular mortality
- Allows immediate commencement of vagal nerve stimulation, which has recently been shown to enhance upper-limb rehabilitation.(PMID:33894832) Our proof-of-concept data shows daily TAN reduces BP and BP variability lasting several months even in drug-resistant hypertensive patients. In this proof-of-concept randomised sham-controlled trial, we will examine whether early TAN on presentation for mechanical thrombectomy improves autonomic function in patients with acute ischaemic stroke by reducing blood pressure lability.
- Being tested
- trans-cutaneous auricular sensory stimulation
- Medical subject headings
- Ischemic Stroke, Thrombotic Stroke, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-cutaneous auricular sensory stimulationDevice
Transcutaneous auricular sensory stimulation
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Active comparator | Electrodes attached bliaterally to tragus nerve region of outer ear, with appropriate device settings to deliver current. Receives: Device: trans-cutaneous auricular sensory stimulation |
| Electrode attachment only. | Sham comparator | Electrodes attached bliaterally to tragus nerve region of outer ear, with device switched off [blinded to operator]. Receives: Device: trans-cutaneous auricular sensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Variability
Coefficient of variation of systolic blood pressure
Measured: 0-24h after mechanical thrombectomy
Secondary outcomes (2)
Systolic Blood Pressure Variability.
Systolic blood pressure standard deviation.
Measured: 0-24h after mechanical thrombectomy
Diastolic Blood Pressure Variability
coefficient of variation- diastolic blood pressure
Measured: 24h after admission for mechanical thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start26 Apr 2023
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gareth L Ackland, PhD FRCA, Principal investigator, William Harvey Research Institute, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417009
- Sponsor's protocol ID
- 314067
- Acronym
- VANS
- Status last verified
- Jul 2025
- First submitted
- 8 Jun 2022
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers who provide a methodologically sound proposal approved by an independent review committee intermediary using deidentified data.
Publications
Ackland GL, Crane D, Ahuja S, Patel A, Martin T, Joseph M, Ottley O, Hameed R, Dias P, Begum S, Schroth J, Hewson R, Del Arroyo AG, Abbott TEF, Bhogal P. Transauricular Vagus Nerve Stimulation in Acute Ischaemic Stroke Requiring Mechanical Thrombectomy: Sham-Controlled, Randomised Device Trial. Transl Stroke Res. 2025 Dec 27;17(1):10. doi: 10.1007/s12975-025-01404-7.
PubMed 41455014Ackland GL, Martin T, Joseph M, Dias P, Hameed R, Gutierrez Del Arroyo A, Hewson R, Abbott TEF, Spooner O, Bhogal P. Transauricular nerve stimulation in acute ischaemic stroke requiring mechanical thrombectomy: Protocol for a phase 2A, proof-of-concept, sham-controlled randomised trial. PLoS One. 2023 Dec 22;18(12):e0289719. doi: 10.1371/journal.pone.0289719. eCollection 2023.
PubMed 38134136
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagal Autonomic Neuromodulation by Transcutaneous Nerve Stimulation in Acute Ischaemic Stroke Requiring Mechanical Thrombectomy.
- ClinicalTrials.gov ID
- NCT05417009
- Acronym / sponsor ID
- VANS / 314067
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Posted 14 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autonomic modulation by transcutaneous vagal nerve stimulation in acute ischaemic stroke requiring mechanical thrombectomy: a phase IIa, sham controlled randomised trial.
Detailed description
Loss of autonomic variability is strongly associated with adverse outcomes after ischaemic stroke. Removing blood clots from the brain by mechanical thrombectomy has revolutionised the management of stroke, but more than 50% of patients do not regain functional independence.(PMID:26898852) Blood pressure (BP) control is important, since low and high BP (BP variability) are strongly associated with poor patient outcomes after thrombectomy. (PMIDs:32961389;31964286) Autonomic dysfunction causes labile blood pressure. Intact autonomic function is required to control blood pressure and potentially improve recovery after stroke. Impairment of baroreflex autonomic function, due to reduced vagal activity is associated with extreme BP variability, leading to further brain injury and cardiovascular complications.(PMID:30371208) Reduced baroreflex control is related to poor patient outcomes after stroke, independent of absolute blood pressure.(PMID:19834010) Reversing baroreflex and vagal dysfunction is, therefore, widely held to have the potential to improve cardiovascular control and patient outcome in this context.(PMID:19834010)
Non-invasive peripheral neuromodulation restores autonomic control. Vagal nerve stimulation improves autonomic control and reverses baroreflex dysfunction (PMIDs:28949064) but this has previously required surgically implanted devices which are expensive and impractical in the context of acute stroke. Afferent Electronic have achieved the same effect as these implantable devices by non-invasive transcutaneous autonomic neuromodulation (TAN). We have used this simple, safe, hand-held, low-cost device to increase vagal activity and baroreflex sensitivity through non-invasive, painless stimulation of nerves located in the outer ear to control blood pressure.
Baroreflex sensitivity can be increased at the bedside by TAN for 30 minutes following acute trauma. If this can be replicated in thrombectomy patients, it will aid recovery and rehabilitation through five complementary mechanisms where it has been clinically demonstrated that increasing vagal nerve activity:
- Restore baroreflex sensitivity;
- Increase blood flow to ischaemic brain tissue through vagal activation.(PMID:27357059)
- Dampen cerebral/systemic inflammation.(PMID:26723020);
- Reduce atrial fibrillation and myocardial injury,(PMIDs:5744003,22739118) which are common after stroke, and independently predict cognitive decline and cardiovascular mortality
- Allows immediate commencement of vagal nerve stimulation, which has recently been shown to enhance upper-limb rehabilitation.(PMID:33894832) Our proof-of-concept data shows daily TAN reduces BP and BP variability lasting several months even in drug-resistant hypertensive patients. In this proof-of-concept randomised sham-controlled trial, we will examine whether early TAN on presentation for mechanical thrombectomy improves autonomic function in patients with acute ischaemic stroke by reducing blood pressure lability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Active comparator | Device: trans-cutaneous auricular sensory stimulationElectrodes attached bliaterally to tragus nerve region of outer ear, with appropriate device settings to deliver current. |
| Electrode attachment only. | Sham comparator | Device: trans-cutaneous auricular sensory stimulationElectrodes attached bliaterally to tragus nerve region of outer ear, with device switched off [blinded to operator]. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing mechanical thrombectomy for acute ischaemic stroke requiring general or sedation.
- Established hypertensive and/or hypertensive on admission for mechanical thrombectomy [systolic BP >140mmHg; diastolic BP >80mmHg]
Key exclusion criteria (4 listed)
- Current participation in a clinical trial of a treatment with a similar biological mechanism.
- Previous enrolment into VANS trial.
- Anatomical or other contraindication to trans-cutaneous auricular sensory stimulation
- Pregnancy.
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 |
|---|---|---|
| trans-cutaneous auricular sensory stimulationTranscutaneous auricular sensory stimulation | Device | Electrode attachment only., Stimulation |
Primary outcome
Blood Pressure Variability
Time frame: 0-24h after mechanical thrombectomy
Coefficient of variation of systolic blood pressure
2 secondary outcomes
Systolic Blood Pressure Variability.
Time frame: 0-24h after mechanical thrombectomy
Diastolic Blood Pressure Variability
Time frame: 24h after admission for mechanical thrombectomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41455014Ackland GL, Crane D, Ahuja S, Patel A, Martin T, Joseph M, Ottley O, Hameed R, Dias P, Begum S, Schroth J, Hewson R, Del Arroyo AG, Abbott TEF, Bhogal P. Transauricular Vagus Nerve Stimulation in Acute Ischaemic Stroke Requiring Mechanical Thrombectomy: Sham-Controlled, Randomised Device Trial. Transl Stroke Res. 2025 Dec 27;17(1):10. doi: 10.1007/s12975-025-01404-7.
- Derived from this study: PubMed 38134136Ackland GL, Martin T, Joseph M, Dias P, Hameed R, Gutierrez Del Arroyo A, Hewson R, Abbott TEF, Spooner O, Bhogal P. Transauricular nerve stimulation in acute ischaemic stroke requiring mechanical thrombectomy: Protocol for a phase 2A, proof-of-concept, sham-controlled randomised trial. PLoS One. 2023 Dec 22;18(12):e0289719. doi: 10.1371/journal.pone.0289719. eCollection 2023.
- Individual participant dataSharing planned: Yes. Researchers who provide a methodologically sound proposal approved by an independent review committee intermediary using deidentified data.
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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.
Gareth L Ackland, PhD FRCA principal investigator
William Harvey Research Institute, Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trans-cutaneous auricular sensory stimulation in people with Ischemic Stroke and Thrombotic Stroke, run by Queen Mary University of London at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 14 Jul 2025. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Variability (time frame: 0-24h after mechanical thrombectomy). 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 NCT05417009, which also lists 2 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 14 Jul 2025.