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Vagus Nerve Stimulation and Stress Reduction Training for Migraine

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ClinicalTrials.gov Identifier: NCT03592329
Recruitment Status : Not yet recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Vitaly Napadow, Ph.D., Lic.Ac., 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.

Condition or disease Intervention/treatment Phase
Migraine Behavioral: Stress Reduction Training A Device: active tVNS Behavioral: Stress Reduction Training B Device: sham tVNS Early Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: active tVNS + SRT A
active tVNS and Stress Reduction Training A
Behavioral: Stress Reduction Training A
twice weekly instructor-led sessions for 8 weeks plus home practice sessions
Other Name: SRT A

Device: active tVNS
non-painful electrical stimulation of the auricle
Other Name: 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 Name: transcutaneous vagus nerve stimulation

Behavioral: Stress Reduction Training B
twice weekly instructor-led sessions for 8 weeks plus home practice sessions
Other Name: SRT B

sham tVNS + SRT A
sham stimulation and Stress Reduction Training A
Behavioral: Stress Reduction Training A
twice weekly instructor-led sessions for 8 weeks plus home practice sessions
Other Name: SRT A

Device: sham tVNS
sham stimulation

sham tVNS + SRT B
sham tVNS and Stress Reduction Training B
Behavioral: Stress Reduction Training B
twice weekly instructor-led sessions for 8 weeks plus home practice sessions
Other Name: SRT B

Device: sham tVNS
sham stimulation




Primary Outcome Measures :
  1. Brain activity changes in migraine patients in response to treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592329


Contacts
Contact: Vitaly Napadow, PhD,Lic.Ac. (617) 286-6670 vitaly@mgh.harvard.edu

Locations
United States, Massachusetts
Anthinoula A. Martinos Center Not yet recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Harrison Fisher    617-286-6670    hfisher2@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Vitaly Napadow Massachusetts General Hospital

Responsible Party: Vitaly Napadow, Ph.D., Lic.Ac., Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03592329     History of Changes
Other Study ID Numbers: P01AT009965 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases