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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Rambam Health Care Campus
Information provided by (Responsible Party):
d_yarnitsky, Rambam Health Care Campus Identifier:
First received: November 9, 2011
Last updated: September 16, 2015
Last verified: September 2015
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 Intervention
Drug: Doluxetine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Therapeutic response to the analgesic drugs [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    The level of pain relief

Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01470352

Contact: David Yarnitsky, MD, PhD 0728542605

Rambam health care campus Recruiting
Haifa, Israel
Contact: David Yarnitsky    9728542605   
Sponsors and Collaborators
  More Information

Responsible Party: d_yarnitsky, Head of Neurology Department, Rambam Health Care Campus Identifier: NCT01470352     History of Changes
Other Study ID Numbers: Migrain-0265-11CTIL 
Study First Received: November 9, 2011
Last Updated: September 16, 2015
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
offset analgesia

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
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents processed this record on October 27, 2016