A trial of stimulating the vagus nerve at the ear for people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
Phase 2
- Conditions
- Myalgic Encephalomyelitis (ME)Nervous System Diseases
- Registration Number
- ISRCTN15931869
- Lead Sponsor
- niversity of Liverpool
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility outcomes:<br>1. Acceptability (followup interviews at 3 months after baseline and 6 months later)<br>2. Recruitability (recruitment rate measured at screening and initial assessment)<br>3. Suitability of outcome measures (completion of outcome measures at baseline and 3 months after baseline plus discussion at interview)<br>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<br>
- Secondary Outcome Measures
Name Time Method Measured at baseline and 3 months later:<br>1. Accelerometer (Axivity AX3) - measures activity levels over 5 days<br>2. Portable metabolic measures (cortex) - Vo2, Vco2, RER<br>3. 10 min stand test measuring BP, Heart rate and pulse oximetry<br>4. Funcap questionnaire - measures functional activity<br>5. EQ5D questionnaire - measures QOL, COMPASS questionnaire measures autonomic nervous system<br>6. Health utilisation questionnaire specifically designed for this study<br>