A trial of stimulating the vagus nerve at the ear for people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

A phase II feasibility trial of transcutaneous auricular vagus nerve stimulation for people with myalgic encephalomyelitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15931869

Enrollment

Registered

2024-08-20

Start date

2024-09-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myalgic Encephalomyelitis (ME) Nervous System Diseases

Interventions

People with ME will be recruited from ME support groups and online ME forums. After informed consent, participants will be randomly divided to either receive transcutaneous auricular vagus nerve stimu

the safety (any side effects of taVNS treatment), what participants think of the treatment and taking part in the trial (via interviews after treatment is complete), and whether the things we measure

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adults with ME (as defined by the International Consensus Primer criteria for ME) 2. Mild to severe ME 3. Live in the Liverpool and Manchester region. The geographical restriction is to make the logistics and costs of visiting participants in their own home feasible

Exclusion criteria

Exclusion criteria: 1. Previous or ongoing use of taVNS (as this study is evaluating first-time use of taVNS) 2. Inability to stand (as this is part of the assessment procedure) 3. Contraindications to Tavns

Design outcomes

Primary

Measure	Time frame
Feasibility outcomes: 1. Acceptability (followup interviews at 3 months after baseline and 6 months later) 2. Recruitability (recruitment rate measured at screening and initial assessment) 3. Suitability of outcome measures (completion of outcome measures at baseline and 3 months after baseline plus discussion at interview) 4. Calculation of sample size (based on outcomes of primary OM - heart rate variability measured with firstbeat devices at baseline and 3 months later) for a definitive study	—

Measure

Time frame

Feasibility outcomes: 1. Acceptability (followup interviews at 3 months after baseline and 6 months later) 2. Recruitability (recruitment rate measured at screening and initial assessment) 3. Suitability of outcome measures (completion of outcome measures at baseline and 3 months after baseline plus discussion at interview) 4. Calculation of sample size (based on outcomes of primary OM - heart rate variability measured with firstbeat devices at baseline and 3 months later) for a definitive study

—

Secondary

Measure	Time frame
Measured at baseline and 3 months later: 1. Accelerometer (Axivity AX3) - measures activity levels over 5 days 2. Portable metabolic measures (cortex) - Vo2, Vco2, RER 3. 10 min stand test measuring BP, Heart rate and pulse oximetry 4. Funcap questionnaire - measures functional activity 5. EQ5D questionnaire - measures QOL, COMPASS questionnaire measures autonomic nervous system 6. Health utilisation questionnaire specifically designed for this study	—

Measure

Time frame

Measured at baseline and 3 months later: 1. Accelerometer (Axivity AX3) - measures activity levels over 5 days 2. Portable metabolic measures (cortex) - Vo2, Vco2, RER 3. 10 min stand test measuring BP, Heart rate and pulse oximetry 4. Funcap questionnaire - measures functional activity 5. EQ5D questionnaire - measures QOL, COMPASS questionnaire measures autonomic nervous system 6. Health utilisation questionnaire specifically designed for this study

—

Countries

England, United Kingdom

Contacts

Public ContactNicola Baker (Clague-Baker)

nicola.baker@liverpool.ac.uk+44 7912950671

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026