Recruiting

Mu-Opioid Mechanism

Sponsor:

University of Michigan

Code:

NCT05769348

Conditions

Chronic Migraine

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

HD-tDCS Active Protocol

HD-tDCS Sham Protocol

Study Details

Brief 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.

Conditions

Chronic Migraine

Study ID

NCT05769348

Start date

Jan 26, 2023

Status verified date

Feb, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Significantly greater pain in body sites other than the head
  • Active, untreated major concurrent systemic illness other than migraine

  • Medical conditions that can impair health status independent of migraine (including cardiopulmonary disorders, malignancy, uncontrolled endocrine or allergies)
  • Systemic rheumatic disorders (i.e., rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia);
  • History or current evidence of a psychotic disorder (e.g., bipolar disorder, schizophrenia) or severe major depression, as evidenced by Beck Depression score of >30\*
  • History of neurological disorder (e.g., epilepsy, stroke, neuropathy, neuropathic pain)
  • Medication overuse headache (ICHD-3), regular intake for ≥10 days per month of ergotamine, triptans, combination analgesics, or any combination thereof OR ≥15 days per month of simple analgesics (acetaminophen, aspirin, NSAID), for more than 3 months
  • Current use of opioid or dopaminergic drugs (or use within the last 3 months) or substance abuse (self-reported)
  • Drug test positive for opioid or recreational drug (e.g., cannabis) at the time of the PET scan visits
  • Allergic response to study radiotracers or chemically related drugs
  • Excluded by MRI Center or PET Center safety screening checklist (as administered by study staff)
  • Pregnant or lactating (negative urine pregnancy test must be available before any PET procedures are initiated)
  • Prior use of tDCS

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

HD-tDCS Active Protocol

non-invasive brain stimulation (active protocol)

HD-tDCS Sham Protocol

non-invasive brain stimulation (sham protocol)

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 and Locations

Central contacts

Jacqueline Dobson, BA

(734)763-8469contactHOPE@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jacqueline Dobson

734-763-8469ContactHOPE@umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-02-25.