Trial results for a study investigating Vagus Nerve Stimulation and Stress Reduction Training for Migraine were posted on ClinicalTrials.gov on 2026-02-25. The study, which enrolled 193 participants, assessed brain activity and inflammation changes in response to an 8-week combination therapy approach, with the active treatment group showing a mean brain activity change of -0.249 Log ratio % signal change (Insula/Sp5).
Background
Migraine is a debilitating neurological condition characterized by severe headaches and other symptoms. Research into migraine often focuses on understanding underlying neurological processes, including brain activity and inflammation, which are believed to play a role in its pathology. This trial aimed to assess a combination therapy approach involving vagus nerve stimulation and stress reduction training to observe its effects on these biological markers in migraine patients.
Trial design
This completed study, designated as Phase NA, enrolled a total of 193 subjects with Migraine. The trial design included two main components: a cross-sectional assessment comparing migraine patients to healthy controls, and an 8-week assessment of a combination therapy approach. The treatment arms included:
- Active Vagus Nerve Stimulation (tVNS) combined with Mindfulness-Based Stress Reduction (MBSR)
- Active tVNS combined with Non-specific Education Control (NEC)
- Sham tVNS combined with MBSR
- Sham tVNS combined with NEC
The study evaluated changes in brain activity and inflammation in response to these interventions.
Key results
The trial reported several key measurements related to brain activity and inflammation:
- Brain Activity Changes in Migraine Patients in Response to Treatment (units: Log ratio % signal change (Insula/Sp5)):
- Active tVNS + MBSR group: mean of -0.249 (Standard Deviation 1.17)
- Active tVNS + NEC group: mean of 0.679 (Standard Deviation 0.971)
- Sham tVNS + MBSR group: mean of 0.680 (Standard Deviation 1.36)
- Sham tVNS + NEC group: mean of 1.06 (Standard Deviation 1.36)
- Brain Inflammation Changes in Migraine Patients in Response to Treatment (units: Uptake ratio):
- Active tVNS + MBSR group: mean of -0.00668 (Standard Deviation 0.0717)
- Active tVNS + NEC group: mean of -0.0113 (Standard Deviation 0.0709)
- Sham tVNS + MBSR group: mean of 0.0590 (Standard Deviation 0.0867)
- Sham tVNS + NEC group: mean of -0.0234 (Standard Deviation 0.0274)
- Brain Activity Differences Between Migraine Patients and Healthy Controls (units: Percent Signal Change):
- Healthy Controls group: mean of -0.114 (Standard Deviation 0.131)
- Migraine Patients group: mean of 0.0146 (Standard Deviation 0.155)
- Brain Inflammation Differences Between Migraine Patients and Healthy Controls (units: Uptake ratio):
- Healthy Controls group: mean of 0.974 (Standard Deviation 0.070)
- Migraine Patients group: mean of 0.989 (Standard Deviation 0.0875)
What this means
The results indicate varying effects on brain activity and inflammation across the different treatment groups for migraine patients. Specifically, the Active tVNS + MBSR group showed a negative mean change in brain activity (-0.249 Log ratio % signal change) and a negative mean change in brain inflammation (-0.00668 Uptake ratio), suggesting a reduction in these markers with this combined therapy. Other groups showed different mean changes, with some positive values indicating increases. The cross-sectional assessment showed differences in baseline brain activity and inflammation between migraine patients and healthy controls, with migraine patients having a mean brain activity of 0.0146 Percent Signal Change compared to -0.114 in healthy controls, and a mean inflammation uptake ratio of 0.989 compared to 0.974 in healthy controls. These findings provide insights into the physiological effects of vagus nerve stimulation and stress reduction training in migraine.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03592329, titled "Vagus Nerve Stimulation and Stress Reduction Training for Migraine", were posted on 2026-02-25 on clinicaltrials.gov.