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New treatment option for Chronic Migraine
Official title Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
ClinicalTrials.gov ID: NCT05769348
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- 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 likely can't join 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...
- 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...
- History of neurological disorder (e.g., epilepsy, stroke, neuropathy, neuropathic pain)
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.