Disease × agent evidence record

Transcutaneous Vagus Nerve Stimulation for ME/CFS: evidence, trials and status

Trials of Transcutaneous Vagus Nerve Stimulation in ME/CFS are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest.

1 registered trials 0 recruiting 17 publications Evidence tier C · Preliminary Score 25.0
Research Tracker › Pairs › ME/CFS › Transcutaneous Vagus Nerve Stimulation
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Transcutaneous Vagus Nerve Stimulation is tracked by OSMF as an investigational option for ME/CFS; no regulator has approved it for this indication, and most post-viral conditions have no approved disease-modifying therapy at all. ClinicalTrials.gov lists 1 registered trial linking Transcutaneous Vagus Nerve Stimulation to ME/CFS: 1 is active or not yet recruiting. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 48 participants. Registered activity dates to 2025. The literature layer holds 17 publications for this pair: 17 PubMed search records. Publication years run from 2025 to 2026. Items here are search-derived or curated references rather than classified trial reports; treat them as leads to read, not as graded evidence.

Myalgic Encephalomyelitis / Chronic Fatigue Syndrome is tracked on the OSMF post-viral programme alongside ME/CFS, Long COVID, POTS and MCAS. Across the programme, 191 candidate agents are logged for ME/CFS, most of them preliminary; this page isolates the record for one of them.

Open in Repurposing ExplorerAgent page: Transcutaneous Vagus Nerve StimulationME/CFS hubME/CFS biomarkers & interventionsPubChem

Evidence table

Evidence tierC · Preliminary
Evidence score25.0 (trials 3.0, literature 17.0, tier 5, approved bonus 0.0)
Registered trials1 total: 0 recruiting, 1 active / not yet recruiting, 0 completed, 0 other
Linked publications17 (17 PubMed search records)
Agent typeDevice (Medical Device)
Development stage (any indication)Investigational
Mechanism / classNeurological / Autonomic
Data sourcesOSMF therapeutic agent database, ClinicalTrials.gov, PubMed
How the evidence score is calculated
  • Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
  • Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
  • The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
  • Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
  • The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.

Registered clinical trials

NCT IDTitleStatusPhaseEnrolment
NCT06968104Vagus Nerve Stimulation to the Ear to Improve Symptoms in Post-COVID-19 and ME/CFS
University of Luxembourg · 2025
active, not recruitingNot applicable48

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Published literature

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Mechanism and notes

Recorded mechanism or class: Neurological / Autonomic.

Clinical notes: Investigational for listed conditions. 1 associated trial(s) and 0 study reference(s) in current data. Review primary sources and consult specialists before use.

Safety: Limited specific safety data in these populations. Review full prescribing information and consult specialist. Many agents used off-label or investigational.

Dosing in studies: See linked studies/trials for reported doses and durations; typical protocols vary widely.

Frequently asked questions

Is Transcutaneous Vagus Nerve Stimulation approved for ME/CFS?

Transcutaneous Vagus Nerve Stimulation is tracked by OSMF as an investigational option for ME/CFS; no regulator has approved it for this indication, and most post-viral conditions have no approved disease-modifying therapy at all. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.

Is Transcutaneous Vagus Nerve Stimulation in clinical trials for ME/CFS?

ClinicalTrials.gov lists 1 registered trial linking Transcutaneous Vagus Nerve Stimulation to ME/CFS: 1 is active or not yet recruiting. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 48 participants. Registered activity dates to 2025.

What does the evidence show for Transcutaneous Vagus Nerve Stimulation in ME/CFS?

Trials of Transcutaneous Vagus Nerve Stimulation in ME/CFS are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. OSMF's existing evidence tier for this pair is C (Preliminary), taken from the OSMF therapeutic agent database, which grades agents by the volume and design of condition-specific evidence rather than by effect size.

Cite this page

Open Source Medicine Foundation. Transcutaneous Vagus Nerve Stimulation for ME/CFS: evidence, trials and status. OSMF Research Tracker. Updated 2026-10-07. https://research.opensourcemed.info/pairs/me-cfs/transcutaneous-vagus-nerve-stimulation.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-10-07. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.