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

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ClinicalTrials.gov Identifier: NCT01470352
Recruitment Status : Recruiting
First Posted : November 11, 2011
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
d_yarnitsky, Rambam Health Care Campus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Doluxetine Drug: Placebo Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2011
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Doluxetine
30 mg/d
Other Name: duloxetine
Drug: Placebo
suger pill 30mg/d
Other Name: sugar
Active Comparator: treatment
Duloxetine will be given in a daily dose of 30 mg for 5 weeks
Drug: Doluxetine
30 mg/d
Other Name: duloxetine
Drug: Placebo
suger pill 30mg/d
Other Name: sugar



Primary Outcome Measures :
  1. Therapeutic response to the analgesic drugs [ Time Frame: 2 month ]
    The level of pain relief



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470352


Contacts
Contact: David Yarnitsky, MD, PhD 0728542605 d_yarnitsky@rambam.health.gov.il

Locations
Israel
Rambam health care campus Recruiting
Haifa, Israel
Contact: David Yarnitsky    9728542605    d_yarnitsky@rambam.health.gov.il   
Sponsors and Collaborators
d_yarnitsky

Responsible Party: d_yarnitsky, Head of Neurology Department, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01470352     History of Changes
Other Study ID Numbers: Migrain-0265-11CTIL
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

Keywords provided by d_yarnitsky, Rambam Health Care Campus:
migraine
pain
CPM
offset analgesia
fMRI

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents