Health TrialsbyHealthPanel

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

ConditionChronic Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged 18 to 65 (inclusive)

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.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • HD-tDCS Active Protocol

    Device

    non-invasive brain stimulation (active protocol)

  • HD-tDCS Sham Protocol

    Device

    non-invasive brain stimulation (sham protocol)

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Active Unilateral TreatmentActive comparator 1 intervention
Group B: Active Bilateral TreatmentActive comparator 1 intervention
Group C: Sham TreatmentSham comparator 1 intervention
Group D: No TreatmentNo intervention 0 interventions

Trial outcomes

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.

Time frame
baseline to 1 month follow-up

Secondary outcomes

1

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

Day with a headache that lasts at least 2 hours, OR day with a headache that is treated by an acute headache medication.

Time frame
baseline to 1 month follow-up
2

Responder rate over 1-month follow-up

50% percent reduction (from baseline to post tDCS) in the number of moderate or severe headache days.

Time frame
baseline to 1 month follow-up
3

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

\- Medication use is defined as a day when the patient reports intake of medication for the acute treatment of headache

Time frame
baseline to 1 month follow-up
4

Intensity of headache over 1-month follow-up

Each headache day is rated in terms of maximum intensity on a 0 to 10 NRS scale and averaged headache intensity will be used.

Time frame
baseline to 1 month follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
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