Adults 18 to 65, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Brain Activity Changes in Migraine Patients in Response to TreatmentPrimary· 8 weeks (i.e. post-treatment)
Post-treatment versus baseline change in intervention-evoked cortical amplification ratio (left posterior insula to spinal trigeminal nucleus ratio of fMRI BOLD percent signal change) for trigeminal afferent stimulation (i.e. forehead stimulation).
Group
Value
95% CI
Active tVNS + MBSR
-0.249
± 1.17
Active tVNS + NEC
0.679
± 0.971
Sham tVNS + MBSR
0.680
± 1.36
Sham tVNS + NEC
1.06
± 1.36
Brain Inflammation Changes in Migraine Patients in Response to TreatmentPrimary· 8 weeks (post-treatment)
PET \[11C\]PBR28 signal, quantified as Standardized Uptake Value Ratio (SUVR; i.e., tissue radioactivity / injected dose / weight) change from baseline to post-treatment, compared across treatment groups for migraine patients. \[11C\]PBR28 SUVR was measured in the insula (average of left and right insula), using cerebellum SUV as a pseudo-reference region.
Group
Value
95% CI
Active tVNS + MBSR
-0.00668
± 0.0717
Active tVNS + NEC
-0.0113
± 0.0709
Sham tVNS + MBSR
0.0590
± 0.0867
Sham tVNS + NEC Sham tVNS + NEC Sham tVNS + NEC
-0.0234
± 0.0274
Brain Activity Differences Between Migraine Patients and Healthy ControlsSecondary· Week 0-3 (Baseline window)
Amygdala fMRI BOLD signal differences from stressful imagery task (percent BOLD signal change, negative minus neutral image blocks), contrasting migraine patients (at baseline) and healthy controls.
Group
Value
95% CI
Healthy Controls
-0.114
± 0.131
Migraine Patients
0.0146
± 0.155
Brain Inflammation Differences Between Migraine Patients and Healthy ControlsSecondary· Week 0-3 (Baseline window)
PET \[11C\]PBR28 signal, quantified as Standardized Uptake Value Ratio (SUVR; i.e., tissue radioactivity / injected dose / weight), differences between healthy controls and migraine patients at baseline. \[11C\]PBR28 SUVR was measured in the insula (average of left and right insula), using cerebellum SUV as a pseudo-reference region.
The Headache Impact Test (HIT-6) is a 6-item self-report evaluation of headache disability. The HIT6 is measured on a scale from 36 to 78 points, with higher scores indicating greater headache-related disability. Participants completed the HIT-6 at baseline and post-treatment. The reported outcome measure is a difference score (post-treatment HIT-6 minus baseline HIT-6).
The Pain Catastrophizing Scale (PCS) is a 13-item evaluation of a participant's subjective pain experience. The PCS is measured on a scale from 0 to 52 points, with higher scores indicating a greater degree of pain catastrophizing. The PCS includes three subscales (Rumination, Magnification, and Helplessness), and the scores from the subscales were summed to determine the total score. Participants completed the PCS at baseline and post-treatment. The reported outcome measure is a difference score (post-treatment PCS minus baseline PCS).
Group
Value
95% CI
Active tVNS + MBSR
-5.26
± 5.69
Active tVNS + NEC
-1.48
± 4.89
Sham tVNS + MBSR
-0.47
± 4.87
Sham tVNS + NEC
-3.94
± 4.58
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected over the 6 months that participants were in the study..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study design has two components: 1) a cross-sectional assessment of brain activity and inflammation in migraine patients compared to healthy controls and 2) an assessment of 8 weeks of a combination therapy approach to treating migraine.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07419607 — MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducat
· NA
· recruiting
NCT07487701 — Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study
· NA
· active not recruiting
NCT07343427 — Impact of GON PRF on Central Sensitization in Migraine Patients
· NA
· active not recruiting
NCT07336056 — Nerivio Efficacy Under High-Frequency Use
· Phase 4
· active not recruiting
NCT07385755 — Desvenlafaxine for Preventive Treatment of Frequent Migraines
· NA
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 25 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03592329.