Vagus Nerve Stimulation and Stress Reduction Training for Migraine

Not Applicable

• Conditions: Migraine
• Interventions: Behavioral: Stress Reduction Training A; Device: active tVNS; Behavioral: Stress Reduction Training B; Device: sham tVNS

• Registration Number: NCT03592329
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-19
• Study Start: 2019-08-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07
• Primary Completion: 2024-01-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Subjects must be between 18 and 65 years of age.
2. Migraine Diagnosis and general health otherwise.
3. Willingness to attend twice- weekly treatment session at Cambridge Health Alliance for 8 weeks.
4. 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

1. Major illness, psychiatric condition, or neurological disease.
2. 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
3. Any condition that would prohibit MRI scanning

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active tVNS + SRT A	Stress Reduction Training A	active tVNS and Stress Reduction Training A
active tVNS + SRT A	active tVNS	active tVNS and Stress Reduction Training A
active tVNS + SRT B	active tVNS	active tVNS and Stress Reduction Training B
active tVNS + SRT B	Stress Reduction Training B	active tVNS and Stress Reduction Training B
sham tVNS + SRT A	Stress Reduction Training A	sham stimulation and Stress Reduction Training A
sham tVNS + SRT A	sham tVNS	sham stimulation and Stress Reduction Training A
sham tVNS + SRT B	Stress Reduction Training B	sham tVNS and Stress Reduction Training B
sham tVNS + SRT B	sham tVNS	sham tVNS and Stress Reduction Training B

Primary Outcome Measures

Name	Time	Method
Brain activity changes in migraine patients in response to treatment	8 weeks post treatment	fMRI BOLD signal (percent BOLD signal change) from baseline to post-treatment, compared across treatment groups.
Brain inflammation changes in migraine patients in response to treatment	8 weeks post treatment	PET \[11C\]PBR28 signal, quantified as Standardized Uptake Value (SUV; i.e., tissue radioactivity / injected dose / weight) change from baseline to post-treatment, compared across treatment groups for migraine patients.

Secondary Outcome Measures

Name	Time	Method
Brain activity differences between Migraine patients and healthy controls	3 weeks	fMRI BOLD signal differences (percent BOLD signal change) between group maps for migraine patients and healthy controls at baseline
Brain inflammation differences between Migraine patients and healthy controls	3 weeks	PET \[11C\]PBR28 signal, quantified as Standardized Uptake Value (SUV; i.e., tissue radioactivity / injected dose / weight), differences between healthy controls and migraine patients at baseline.

Trial Locations

Locations (1)

Anthinoula A. Martinos Center; 🇺🇸 Charlestown, Massachusetts, United States