Clinical trial NCT03592329: Vagus Nerve Stimulation and Stress Reduction Training for Migraine
Official title: Brain Mechanisms of Vagus Nerve Stimulation and Stress Reduction Training for Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-07-19
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brain activity changes in migraine patients in response to treatment
timeFrame: 8 weeks post treatment
measure: Brain inflammation changes in migraine patients in response to treatment
timeFrame: 8 weeks post treatment
Secondary outcomes:
measure: Brain activity differences between Migraine patients and healthy controls
timeFrame: 3 weeks
measure: Brain inflammation differences between Migraine patients and healthy controls
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Anthinoula A. Martinos Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Vitaly Napadow, PhD,Lic.Ac.
role: PRINCIPAL_INVESTIGATOR
References: