Vagus Nerve Stimulation and Stress Reduction Training for Migraine

Migraine Clinical Trial

Official title:

Brain Mechanisms of Vagus Nerve Stimulation and Stress Reduction Training for Migraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03592329
• Other study ID #: 2018P001184
• Secondary ID: P01AT009965
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2022
• Source: Massachusetts General Hospital
• Contact: Kassandra Round
• Phone: (617) 952-6481
• Email: MigraineRelief[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Stress Reduction Training A
twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions

Device:
• active tVNS
non-painful electrical stimulation of the auricle

Behavioral:
• Stress Reduction Training B
twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions

Device:
• sham tVNS
sham stimulation

Locations

Country	Name	City	State
United States	Anthinoula A. Martinos Center	Charlestown	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity changes in migraine patients in response to treatment	fMRI BOLD signal (percent BOLD signal change) from baseline to post-treatment, compared across treatment groups.	8 weeks post treatment
Primary	Brain inflammation changes in migraine patients in response to 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.	8 weeks post treatment
Secondary	Brain activity differences between Migraine patients and healthy controls	fMRI BOLD signal differences (percent BOLD signal change) between group maps for migraine patients and healthy controls at baseline	3 weeks
Secondary	Brain inflammation differences between Migraine patients and healthy controls	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.	3 weeks