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

NCT05769348 | Recruiting FDA Device

• 2 other identifiers: HUM00213295R01NS094413
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Headache Day: day with a headache that causes moderate or severe pain (at its peak, defined as NRS ≥ 4) that lasts at least 4 hours, OR day with a headache that is treated by an acute headache medication.

  baseline to 1 month follow-up

Secondary Outcomes (4)

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

  baseline to 1 month follow-up

• Responder rate over 1-month follow-up

  baseline to 1 month follow-up

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

  baseline to 1 month follow-up

• Intensity of headache over 1-month follow-up

  baseline to 1 month follow-up

Study Arms (4)

Active Unilateral Treatment

ACTIVE COMPARATOR

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).

Device: HD-tDCS Active Protocol

Active Bilateral Treatment

ACTIVE COMPARATOR

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).

Device: HD-tDCS Active Protocol

Sham Treatment

SHAM COMPARATOR

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).

Device: HD-tDCS Sham Protocol

No Treatment

NO 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).

Interventions

HD-tDCS Active Protocol DEVICE

non-invasive brain stimulation (active protocol)

Active Bilateral Treatment; Active Unilateral Treatment

HD-tDCS Sham Protocol DEVICE

non-invasive brain stimulation (sham protocol)

Sham Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

• Alexandre DaSilva, DDS, DMedSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Dobson, BA

CONTACT

(734)763-8469; contactHOPE@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will not know if they are receiving active or sham treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Headache and Orafacial Pain Effort Lab

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 15, 2023
• Study Start: January 26, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)