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Device

VNS + Stress Reduction for Migraine

N/A
Recruiting
Led By Vitaly Napadow, PhD,Lic.Ac.
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be between 18 and 65 years of age
Healthy Volunteers between the ages of 18 and 65 can participate in this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks post treatment
Awards & highlights

Study Summary

This trial is studying the effects of a combination therapy approach to treating migraine compared to usual care. Brain activity and inflammation will be assessed to see if the combination therapy is effective.

Who is the study for?
This trial is for adults aged 18-65 with migraines who can attend treatment sessions in English at Cambridge Health Alliance twice a week for 8 weeks. It's not for those experienced in stress reduction or certain physical activities, nor anyone with major illnesses, psychiatric conditions, neurological diseases, or issues that prevent MRI scans.Check my eligibility
What is being tested?
The study tests how well vagus nerve stimulation (active tVNS or sham) combined with one of two different Stress Reduction Training programs helps manage migraines over an 8-week period compared to the brain activity and inflammation levels in healthy individuals.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include discomfort from wearing the tVNS device and potential emotional distress during stress reduction training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I am a healthy volunteer aged between 18 and 65.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain activity changes in migraine patients in response to treatment
Brain inflammation changes in migraine patients in response to treatment
Secondary outcome measures
Brain activity differences between Migraine patients and healthy controls
Brain inflammation differences between Migraine patients and healthy controls

Trial Design

4Treatment groups
Experimental Treatment
Group I: sham tVNS + SRT BExperimental Treatment2 Interventions
sham tVNS and Stress Reduction Training B
Group II: sham tVNS + SRT AExperimental Treatment2 Interventions
sham stimulation and Stress Reduction Training A
Group III: active tVNS + SRT BExperimental Treatment2 Interventions
active tVNS and Stress Reduction Training B
Group IV: active tVNS + SRT AExperimental Treatment2 Interventions
active tVNS and Stress Reduction Training A
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sham tVNS
2019
N/A
~100
active tVNS
2019
N/A
~20

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
833 Previous Clinical Trials
669,303 Total Patients Enrolled
11 Trials studying Migraine
1,326 Patients Enrolled for Migraine
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,726 Total Patients Enrolled
2 Trials studying Migraine
379 Patients Enrolled for Migraine
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,331 Total Patients Enrolled
5 Trials studying Migraine
228 Patients Enrolled for Migraine

Media Library

active tVNS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03592329 — N/A
Migraine Research Study Groups: sham tVNS + SRT A, active tVNS + SRT B, sham tVNS + SRT B, active tVNS + SRT A
Migraine Clinical Trial 2023: active tVNS Highlights & Side Effects. Trial Name: NCT03592329 — N/A
active tVNS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03592329 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this research endeavor?

"Affirmative, the information hosted on clinicaltrials.gov makes evident that this medical trail is currently recruiting patients. It was first published on August 20th 2019 and had its most recent update posted on April 6th 2022. The study requires 150 participants from 1 site to enroll in it."

Answered by AI

Are there any slots still available for those wishing to join this medical trial?

"Affirmative. Perusal of the clinicaltrials.gov records reveals that this trial was initially posted on August 20th 2019, and has been actively recruiting since April 6th 2022. 150 individuals need to be enrolled at 1 site for full completion of the study."

Answered by AI

Are there any eligibility requirements I must meet to join this research?

"To qualify for this medical trial, potential participants should suffer from migraine and be between 18-65 years old. The research team is currently seeking around 150 individuals to take part in the study."

Answered by AI

Does this research include adults aged 30 and up?

"According to the trial's eligibility requirements, only individuals aged 18-65 are qualified participants. Those too young or old can look into 32 and 117 clinical trials respectively that cater to their age group."

Answered by AI

Who else is applying?

What site did they apply to?
Anthinoula A. Martinos Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Vagus Nerve Stimulation and Stress Reduction Training for Migraine
Vitaly Napadow, Ph.D., Lic.Ac. 2019. "Vagus Nerve Stimulation and Stress Reduction Training for Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03592329.
All > Migraine Headaches > Migraine
~26 spots leftby Apr 2025
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