Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study investigates whether unilateral and bilateral non-invasive brain stimulation, given for 20 minutes/once per day for twenty days (M-F) can reduce migraine pain. Fourty patients will receive treatment (20 unilateral treatment, and 20 bilateral treatment), while twenty will receive a sham procedure. Another 20 Episodic Migraine patients will be recruited for the observational aim of the study which does not include brain stimulation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

• Willing to limit the introduction of new treatments and medications during the study period.

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Jacqueline Dobson, BA
contactHOPE@umich.edu
(734)763-8469
Time Frame
Start Date: 2023-01-26
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 80
Treatments
Active_comparator: Active Unilateral Treatment
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).
Active_comparator: Active Bilateral Treatment
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).
Sham_comparator: Sham Treatment
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).
No_intervention: No Treatment
Episodic Migraine Patients will not receive study treatment. These patients will complete observational study components (Screening visit, baseline visit, MRI and PET scan only).
Related Therapeutic Areas
Sponsors
Leads: University of Michigan
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov