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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05769348
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • HD-tDCS Active Protocol — DEVICE
    non-invasive brain stimulation (active protocol)
  • HD-tDCS Sham Protocol — DEVICE
    non-invasive brain stimulation (sham protocol)

Study Details

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.

Key Dates

Start date
Jan 26, 2023
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Change from baseline in moderate to severe headache days over 1 month follow-up [ Time Frame: baseline to 1 month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Jacqueline Dobson
[email protected]
734-763-8469

Find similar trials in Ann Arbor, MI

By condition
Migraine
By specialty
Neurology
By research site
University of Michigan· Ann Arbor, MI

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