Vagus Nerve Stimulation and Stress Reduction Training for Migraine

Mass General Brigham

Status: Completed

Conditions: Migraine

Treatments: Device: sham tVNS; Device: active tVNS; Behavioral: Stress Reduction Training B; Behavioral: Stress Reduction Training A

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03592329

P01AT009965 (U.S. NIH Grant/Contract)

2018P001184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 193 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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193 participants in 4 patient groups

active tVNS + SRT A

Experimental group

Description:

active tVNS and Stress Reduction Training A

Treatment:

Behavioral: Stress Reduction Training A

Device: active tVNS

active tVNS + SRT B

Experimental group

Description:

active tVNS and Stress Reduction Training B

Treatment:

Behavioral: Stress Reduction Training B

Device: active tVNS

sham tVNS + SRT A

Other group

Description:

sham stimulation and Stress Reduction Training A

Treatment:

Behavioral: Stress Reduction Training A

Device: sham tVNS

sham tVNS + SRT B

Other group

Description:

sham tVNS and Stress Reduction Training B

Treatment:

Behavioral: Stress Reduction Training B

Device: sham tVNS