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Completed

NCT Number: NCT03592329

Vagus Nerve Stimulation and Stress Reduction Training for Migraine

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anthinoula A. Martinos Center

Charlestown, Massachusetts, 02129, United States

About this study

Chronic pain is the most prevalent and disabling medical condition, and no single therapy has proven to be completely successful for alleviating pain, such as migraine headache. It is well documented, and recommended in the recent Institute of Medicine (IOM) report, that a multimodal approach is optimal for pain management. This study will evaluate a combination transcutaneous vagus nerve stimulation and stress reduction training for migraine.

Investigators will recruit participants who have migraines and randomize to one of four potential treatment arms (real or sham stimulation + real or sham stress reduction training). Brain imaging (MRI and PET) and clinical data will be collected before and after 8 weeks of the combination therapy.

Healthy controls will also be recruited for collection of the same baseline brain imaging and clinical data, but with no treatment or second data collection phase.

Findings from this research will help elucidate brain activity and inflammation associated with migraines and evaluate the efficacy of the combination therapy in reducing migraine.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be between 18 and 65 years of age.
  • Migraine Diagnosis and general health otherwise.
  • Willingness to attend twice- weekly treatment session at Cambridge Health Alliance for 8 weeks.
  • Able to give written consent and participate in group interventions in English.

Healthy Volunteers between the ages of 18 and 65 can participate in this study.

Exclusion criteria

  • Major illness, psychiatric condition, or neurological disease.
  • Previous experience with stress reduction training (such as mindfulness training, MBSR, MBCT, Relaxation Response) or more than 15 home mediation practice sessions in the past month, or more than 10 classes in yoga, Tai Chi, or Qi Gong in the past 3 months
  • Any condition that would prohibit MRI scanning

Healthy Volunteers have the same eligibility constraints with the addition of current or past history of migraine.

Treatment and study plan

Stress Reduction Training A

Behavioral

twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions

Other names: SRT A

active tVNS

Device

non-painful electrical stimulation of the auricle

Other names: transcutaneous vagus nerve stimulation

Stress Reduction Training B

Behavioral

twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions

Other names: SRT B

Sham tVNS

Device

sham stimulation

Primary outcomes

  1. Brain Activity Changes in Migraine Patients in Response to Treatment

    Time frame: 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).

  2. Brain Inflammation Changes in Migraine Patients in Response to Treatment

    Time frame: 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.

Secondary outcomes

  1. Brain Activity Differences Between Migraine Patients and Healthy Controls

    Time frame: 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.

  2. Brain Inflammation Differences Between Migraine Patients and Healthy Controls

    Time frame: 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.

Other outcomes

  1. Primary Clinical Outcome (HIT6)

    Time frame: 8 weeks (post-treatment)

    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).

  2. Secondary Clinical Outcome (PCS)

    Time frame: 8 weeks (post-treatment)

    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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Brain Mechanisms of Vagus Nerve Stimulation and Stress Reduction Training for Migraine

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2018
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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