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Vagus Nerve Stimulation and Stress Reduction Training for Migraine

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03592329
Collaborator
National Institutes of Health (NIH) (NIH), National Center for Complementary and Integrative Health (NCCIH) (NIH)
150
Enrollment
1
Location
4
Arms
59.4
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Stress Reduction Training A
  • Device: active tVNS
  • Behavioral: Stress Reduction Training B
  • Device: sham tVNS
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Brain Mechanisms of Vagus Nerve Stimulation and Stress Reduction Training for Migraine
Actual Study Start Date :
Aug 20, 2019
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. 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

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anthinoula A. Martinos Center Charlestown Massachusetts United States 02129

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Vitaly Napadow, PhD,Lic.Ac., Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vitaly Napadow, Ph.D., Lic.Ac., Associate Professor, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT03592329
    Other Study ID Numbers:
    • 2018P001184
    • P01AT009965
    First Posted:
    Jul 19, 2018
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of Apr 7, 2022