Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
active tVNS + SRT A
active tVNS and Stress Reduction Training A
  • Behavioral: Stress Reduction Training A
    twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
    Other names:
    • SRT A
  • Device: active tVNS
    non-painful electrical stimulation of the auricle
    Other names:
    • transcutaneous vagus nerve stimulation
Experimental
active tVNS + SRT B
active tVNS and Stress Reduction Training B
  • Device: active tVNS
    non-painful electrical stimulation of the auricle
    Other names:
    • transcutaneous vagus nerve stimulation
  • Behavioral: Stress Reduction Training B
    twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
    Other names:
    • SRT B
Other
sham tVNS + SRT A
sham stimulation and Stress Reduction Training A
  • Behavioral: Stress Reduction Training A
    twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
    Other names:
    • SRT A
  • Device: sham tVNS
    sham stimulation
Other
sham tVNS + SRT B
sham tVNS and Stress Reduction Training B
  • Behavioral: Stress Reduction Training B
    twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
    Other names:
    • SRT B
  • Device: sham tVNS
    sham stimulation

Recruiting Locations

Anthinoula A. Martinos Center
Charlestown, Massachusetts 02129
Contact:
Kassandra Round, B.A.
617-952-6481
kround@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Kassandra Round
(617) 952-6481
MigraineRelief@partners.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.