RECRUITING

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

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Conditions

Chronic Migraine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-26
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05769348

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, aged 18 to 65 (inclusive)
  2. * Patients must have Episodic migraines that started before the age of 50, and currently experience:
  3. * 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.
  4. * Episodic migraine (low frequency), specifically those with headache occurring less than 8 days/month.
  5. * Willing to limit the introduction of new treatments and medications during the study period.
  1. * Significantly greater pain in body sites other than the head
  2. * Active, untreated major concurrent systemic illness other than migraine
  3. * Medical conditions that can impair health status independent of migraine (including cardiopulmonary disorders, malignancy, uncontrolled endocrine or allergies)
  4. * Systemic rheumatic disorders (i.e., rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia);
  5. * 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\*
  6. * History of neurological disorder (e.g., epilepsy, stroke, neuropathy, neuropathic pain)
  7. * 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
  8. * Current use of opioid or dopaminergic drugs (or use within the last 3 months) or substance abuse (self-reported)
  9. * Drug test positive for opioid or recreational drug (e.g., cannabis) at the time of the PET scan visits
  10. * Allergic response to study radiotracers or chemically related drugs
  11. * Excluded by MRI Center or PET Center safety screening checklist (as administered by study staff)
  12. * Pregnant or lactating (negative urine pregnancy test must be available before any PET procedures are initiated)
  13. * Prior use of tDCS

Contacts and Locations

Study Contact

Jacqueline Dobson, BA
CONTACT
(734)763-8469
contactHOPE@umich.edu

Principal Investigator

Alexandre DaSilva, DDS, DMedSc
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Alexandre DaSilva, DDS, DMedSc, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-26
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2023-01-26
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Migraine