Multiparametric MRI Study of Endogenous Analgesia and Prediction the Efficacy of Migraine Pharmacological Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-16

Study Completion Date

2017-11-06

Brief Summary

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To delineate brain mechanisms that subserve EA in the healthy state and to identify alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance. Individuals with migraine will be examined between episodes in order to assess basal alterations in the efficiency of spatial and temporal filtering of noxious information. This population provides the unique opportunity to examine such processes without confounds arising from ongoing pain.

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Detailed Description

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Pain is a uniquely individual experience that is powerfully shaped by the action of descending control mechanisms. These systems may play crucial roles in the moment-to-moment tuning of the sensitivity, spatial, and temporal response characteristics of nociceptive processing mechanisms during both acute and pathological pain states. However, these systems remain poorly understood in human subjects. The proposed research will use psychophysics and multiparametric MRI to (i) delineate the brain mechanisms that subserve and regulate endogenous analgesia (EA) in the healthy state and (ii) to identify alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance. In both healthy subjects and chronic pain patients, EA will be probed using the DNIC (diffuse noxious inhibitory controls) and offset analgesia paradigms. Functional MRI will examine activation of brainstem mechanisms important in EA, while both functional and structural connectivity analyses will assess the regulation of these brainstem mechanisms by cerebral cortical regions involved in attention and affect. One pathological painful condition, migraine, will be examined since it allows changes in EA associated with chronic pain to be investigated between episodes of pain. Finally, EA and EA associated structural and functional parameters will be used to predict the efficacy of one compound, amitriptyline, to treat migraine in individual patients. Taken together, the proposed research will provide substantial insights into basic mechanisms supporting and regulating EA and can provide a foundation for mechanism-based individualized choice of therapy that may benefit all chronic pain patients.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Doluxetine

Intervention Type DRUG

30 mg/d

Placebo

Intervention Type DRUG

suger pill 30mg/d

treatment

Duloxetine will be given in a daily dose of 30 mg for 5 weeks

Group Type ACTIVE_COMPARATOR

Doluxetine

Intervention Type DRUG

30 mg/d

Placebo

Intervention Type DRUG

suger pill 30mg/d

Interventions

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Doluxetine

30 mg/d

Intervention Type DRUG

Placebo

suger pill 30mg/d

Intervention Type DRUG

Other Intervention Names

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duloxetine sugar

Eligibility Criteria

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Inclusion Criteria

* patients diagnosed with migraine based on the International Headache Society (IHS) criteria 1 that have \>4 attacks/month, both with and without aura

Exclusion Criteria

* patients receiving any migraine preventive treatment during last 3 months or prior treatment with amytriptiline
* other chronic pain conditions
* psychiatric, other neurological diseases, language barrier or cognitive dysfunction

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes