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Brain Stimulation for Migraine

N/A

Recruiting

Led By Alexandre DaSilva, DDS, DMedSc

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1 month follow-up

Summary

This trial tests if 20 minutes of brain stimulation per day for 20 days can reduce migraine pain. 40 patients will get it, 20 a sham procedure, and 20 are observed.

Who is the study for?

This trial is for adults aged 18-65 with episodic migraines that began before age 50. Participants should be willing to avoid new treatments during the study and not have a history of neurological disorders, major illnesses, psychiatric conditions, or substance abuse. Pregnant or breastfeeding individuals are excluded.

What is being tested?

The study tests if non-invasive brain stimulation can reduce migraine pain by administering it once daily for twenty days. Forty patients will receive either unilateral or bilateral treatment, while twenty will undergo a sham procedure without actual stimulation.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, mild headaches, itching under the electrode pads used for brain stimulation, and fatigue. These are typically temporary and resolve after the session.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 1 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 1 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1 month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline in moderate to severe headache days over 1 month follow-up

Secondary study objectives

Change from baseline in headache days over 1-month follow-up

Changes from baseline in medication use days over 1-month follow-up

Intensity of headache over 1-month follow-up

+1 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Active Bilateral TreatmentActive Control1 Intervention

Chronic migraine patients will be randomized (Taves method) to receive BILATERAL high-definition transcranial direct current stimulation (HD-tDCS\*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks).

Group II: No TreatmentActive Control1 Intervention

Episodic Migraine Patients will not receive study treatment. These patients will complete observational study components (Screening visit, baseline visit, MRI and PET scan only).

Group III: Active Unilateral TreatmentActive Control1 Intervention

Chronic migraine patients will be randomized (Taves method) to receive UNILATERAL high-definition transcranial direct current stimulation (HD-tDCS\*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks).

Group IV: Sham TreatmentPlacebo Group1 Intervention

Chronic migraine patients will be randomized (Taves method) to receive SHAM high-definition transcranial direct current stimulation (HD-tDCS\*) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 20 days (M-F for 4 weeks).

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