What side effects are associated with this type of intervention?

Common treatments for migraine include medications like sodium valproate and topiramate, as well as nonpharmacologic interventions such as neuromodulation and acupuncture. Sodium valproate can cause nausea, somnolence, tremor, dizziness, weight gain, and hair loss, and is contraindicated in pregnancy due to teratogenicity. Topiramate may lead to side effects such as weight loss, cognitive impairment, and paresthesia. Neuromodulation techniques, like transcranial magnetic stimulation, can cause lightheadedness, tingling, and tinnitus. Acupuncture generally has fewer adverse effects but may include minor pain or bruising at needle sites.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including triptans like sumatriptan, which can be administered orally or subcutaneously, and are effective in providing rapid relief. Combination therapies, such as sumatriptan and naproxen, have shown enhanced efficacy in clinical trials. Additionally, CGRP receptor antagonists and monoclonal antibodies targeting CGRP and its receptor have been developed for chronic migraine, showing promising results with minimal side effects. These treatments aim to reduce migraine frequency and severity by targeting specific pathways involved in migraine pathogenesis.

What other types of research exist?

Promising novel alternatives for migraine treatment in 2024 include: 1) Lasmiditan, a serotonin receptor agonist approved for acute migraine treatment. 2) Remote Electrical Neuromodulation (REN), which has shown efficacy in relieving acute migraine pain. 3) Single-pulse Transcranial Magnetic Stimulation (sTMS), effective for acute treatment of migraine with aura. 4) Noninvasive Vagus Nerve Stimulation (nVNS), which has demonstrated benefits in acute migraine therapy. These options provide diverse mechanisms of action and can be considered based on individual patient needs and responses.

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Device

VNS + Stress Reduction for Migraine

N/A

Waitlist Available

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

Must not have

Healthy Volunteers have the same eligibility constraints with the addition of current or past history of migraine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of a nerve-stimulating device and stress management training to help people with migraines. The device sends mild electrical signals to calm nerves, while stress management aims to prevent migraines. The study will compare brain activity and inflammation in migraine patients before and after a period of treatment. The nerve-stimulating device used in this trial has been shown to reduce migraine pain intensity in previous studies and is approved for marketing in several countries.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am healthy but have a history of migraines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks post treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain activity changes in migraine patients in response to treatment

Brain inflammation changes in migraine patients in response to treatment

Secondary study objectives

Brain activity differences between Migraine patients and healthy controls

Brain inflammation differences between Migraine patients and healthy controls

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for migraine target various mechanisms to alleviate symptoms and prevent recurrence. Triptans, such as sumatriptan, act as 5-HT1 agonists, which help constrict blood vessels and reduce inflammation by inhibiting the release of inflammatory neuropeptides. Anti-inflammatory agents, like NSAIDs, reduce inflammation and pain by inhibiting cyclooxygenase enzymes. Neuromodulation techniques, including transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS), modulate brain activity and reduce pain perception. These treatments are crucial for migraine patients as they address the underlying pathophysiological mechanisms, providing more effective and targeted relief.

Update on the Pharmacological Treatment of Chronic Migraine.Pharmacological trials in migraine: it's time to reappraise where the headache is and what the pain is like.Acute and preventive treatment of migraine.