Autonomic Neuromodulation by Transcutaneous Nerve Stimulation in Acute Ischaemic Stroke.

NCT05417009 | Completed Results

• 1 other identifier: 314067
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Autonomic modulation by transcutaneous vagal nerve stimulation in acute ischaemic stroke requiring mechanical thrombectomy: a phase IIa, sham controlled randomised trial.

Conditions

Ischemic Stroke; Thrombotic Stroke; Autonomic Dysfunction; Autonomic Imbalance

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Variability

  Coefficient of variation of systolic blood pressure

  0-24h after mechanical thrombectomy

Secondary Outcomes (2)

• Systolic Blood Pressure Variability.

  0-24h after mechanical thrombectomy

• Diastolic Blood Pressure Variability

  24h after admission for mechanical thrombectomy

Study Arms (2)

Stimulation

ACTIVE COMPARATOR

Electrodes attached bliaterally to tragus nerve region of outer ear, with appropriate device settings to deliver current.

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 \[blinded to operator\].

Device: trans-cutaneous auricular sensory stimulation

Interventions

trans-cutaneous auricular sensory stimulation DEVICE

Transcutaneous auricular sensory stimulation

Electrode attachment only.; Stimulation

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing mechanical thrombectomy for acute ischaemic stroke requiring general or sedation.
• Established hypertensive and/or hypertensive on admission for mechanical thrombectomy \[systolic BP \>140mmHg; diastolic BP \>80mmHg\]

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

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, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 41455014 DERIVED

• Ackland 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.

  PMID: 38134136 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Thrombotic Stroke; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autonomic Nervous System Diseases

Results Point of Contact

• Title: Professor Gareth Ackland
• Organization: Queen Mary University of London

g.ackland@qmul.ac.uk

02035940348

Study Officials

• Gareth L Ackland, PhD FRCA

  William Harvey Research Institute, Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sham settings for neuromodulation device.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 14, 2022
• Study Start: April 26, 2023
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: No end date.
• Access Criteria: To achieve aims in approved proposal.

Locations

GB (1)