Outcomes of Migraine Surgery

Vanderbilt University Medical Center

Status: Withdrawn

Conditions: Migraine

Treatments: Procedure: Migraine surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04008303

190993

Details and patient eligibility

About

Migraines are very common and affect over 35 million Americans a year. Migraines can be painful and affect daily life. The cause of migraine is multifactorial and not completely understood. Treatment usually includes different classes of medications, life style changes, physical therapy, acupuncture, nerve stimulators and avoiding common triggers (like bright lights, certain foods, or loud sounds).

For some patients, Botox injected into the muscles of the forehead and neck can significantly reduce pain. Unfortunately, this does not provide long-term relief as the effect of Botox lasts for 3 months. Since year 2000 surgery to treat a selected population of migraine patients has been gaining popularity and showing promising results. The surgery reduces the pressure on the peripheral nerves that are believed to cause migraine headaches by resecting the surrounding tissue (bone, fascia, muscle, and arteries). This surgery provides a more long-term and permanent relief.

The purpose of this study is to follow the effectiveness and outcomes of migraine surgery.

Full description

Migraines are very common and affect over 35 million Americans a year. Migraines can be painful and affect daily life. The cause of migraine is multifactorial and not completely understood. Treatment usually includes different classes of medications, life style changes, physical therapy, acupuncture, nerve stimulators and avoiding common triggers (like bright lights, certain foods, or loud sounds).

For some patients, Botox injected into the muscles of the forehead and neck can significantly reduce pain. Unfortunately, this does not provide long-term relief as the effect of Botox lasts for 3 months. Since year 2000 surgery to treat a selected population of migraine patients has been gaining popularity and showing promising results. The surgery reduces the pressure on the peripheral nerves that are believed to cause migraine headaches by resecting the surrounding tissue (bone, fascia, muscle, and arteries). This surgery provides a more long-term and permanent relief.

The purpose of this study is to follow the effectiveness and outcomes of migraine surgery.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older
• Cleared by neurology and headache specialists for surgery
• Patient cleared by neurology for not having medication overuse headaches
• Patient able to localize a consistent trigger site where the migraines start
• Patient has been suffering from migraine for more than 2 years
• Botox injections or nerve blocks have worked for migraine relief in the past
• Patients formally diagnosed with migraine headaches by a neurologist
• Migraines impact quality of life per MIDAS survey
• No history of Mania, Bipolar disorder, Major Dispersive disorder, or suicidal ideation

Exclusion criteria

• High dose opioid medication use
• Does not meet criteria for migraine diagnosis
• History of prior surgery for migraines

Trial design

0 participants in 1 patient group

Patients with migraines

Description:

Patients seen in clinic and assessed with Migraine Headache Diagnostic Criteria to ensure diagnosis. Patients track the characteristics of migraine headaches for one month before surgery. After this month, patients receive surgery in the operating room for migraine. After surgery, patients track the characteristics of migraine headaches for 3 months. Patients will then be asked to track the characteristics migraine headaches again at 1 year and 2 years and 5 years after surgery. For these time periods, patients only have to keep track of the characteristics for 1 month intervals.

Treatment:

Procedure: Migraine surgery