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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
Male or female, aged 18 to 65 (inclusive)
Patients must have Episodic migraines that started before the age of 50, and currently experience: Chronic migraine (ICHD-3-beta), headache occurring on 15 days/month for more than six months, which, on at least eight days/month, has the features of a migraine headache. Episodic migraine (low frequency), specifically those with headache occurring less than 8 days/month.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1 month follow-up
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I started having migraines before I was 50 and now get them often.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in moderate to severe headache days over 1 month follow-up
Secondary outcome measures
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 moreTrial 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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Who is running the clinical trial?
University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,902 Total Patients Enrolled
2 Trials studying Migraine
76 Patients Enrolled for Migraine
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
649,226 Total Patients Enrolled
8 Trials studying Migraine
1,242 Patients Enrolled for Migraine
Alexandre DaSilva, DDS, DMedScPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Migraine
13 Patients Enrolled for Migraine
Media Library
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for individuals to enroll in this research endeavor?
"This clinical study is still welcoming participants; the details were initialy made available on January 26th 2023 and have been updated as of March 13th."
Answered by AI
Are geriatric individuals being enrolled for this clinical exploration?
"In order to be eligible for this trial, participants need to fall within the age range of 18-65. There are 35 trials dedicated to minors and 114 designed specifically for seniors."
Answered by AI
Could I potentially participate in this medical experiment?
"Eligible participants must be 18 to 65 years old, experience chronic migraines and number approximately 80 in total."
Answered by AI
How many participants are currently taking part in the research project?
"Affirmative. Clinicaltrials.gov verifies that this clinical trial, which first appeared on the 26th of January 2023, is actively recruiting participants. Around 80 test subjects are required from one medical facility."
Answered by AI
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