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Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

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ClinicalTrials.gov Identifier: NCT01970943
Recruitment Status : Completed
First Posted : October 28, 2013
Results First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
David Borsook, Mclean Hospital

Brief Summary:
The placebo effect is a phenomenon that has experienced major advances of its understanding in the last decade. However, mechanisms of placebo analgesia in chronic pain patients have yet to be compared to healthy subjects. The investigators study aims to investigate the magnitude of placebo response and related opioid release in patients that suffer from episodic migraines as compared to healthy controls. In particular, the investigators are looking to map brain activity during placebo analgesia using modern brain imaging techniques such as functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET). The investigators hypothesis is that placebo response and the availability of opioid receptors is reduced in chronic migraine patients.

Condition or disease Intervention/treatment Phase
Migraine Healthy Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
Actual Study Start Date : September 1, 2012
Actual Primary Completion Date : April 30, 2014
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
No Intervention: No Intervention
PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition.
Placebo Comparator: Saline Injection (Placebo)
PET-fMRI investigation on healthy subjects and patients with migraine. Placebo condition.
Other: Placebo
Placebo will be compared to No Intervention.




Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) 0-10 Pain Rating [ Time Frame: 1 day ]

    This study will investigate how placebo may reduce experimental pain induced by contact heat.

    Patients rate heat stimulus intensity on a 0-10 scale, where 0 is no pain, and 10 is most intense pain possible. Data is reported to the placebo condition.

    The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'most intense pain possible'. The patient is asked to mark his pain level on the line between the two endpoints.



Secondary Outcome Measures :
  1. Pain Anticipation fMRI BOLD Signal [ Time Frame: 1 day ]

    We imaged the subjects under an MRI scan. All data was collected on a Siemens 3 Tesla MR scanner using a PETcompatible eight-channel head coil. Structural T1 weighted MPRAGE Functional scans were preprocessed using slice timing correction, realignment, normalization, and smoothing (8 mm FWHM Gaussian filter), using SPM12. In each condition (placebo & no drug) subjects underwent four sets of pain anticipation at high and low temperatures (somatosensory control condition). The stimuli were modeled as boxcar time series, with additional regressors for temperature ramp-up, ramp-down, pain rating sequence, and six motion regressors.data were collected for each of the two PET-MR scans. Contrasts analyzed included pain anticipation.

    The values for the 8 sets of anticipation, for both the migraine and the healthy group are combined


  2. Pain Stimulation fMRI BOLD Signal [ Time Frame: 1 day ]

    We imaged the subjects under an MRI scan. All data was collected on a Siemens 3 Tesla MR scanner using a PETcompatible eight-channel head coil. Structural T1 weighted MPRAGE Functional scans were preprocessed using slice timing correction, realignment, normalization, and smoothing (8 mm FWHM Gaussian filter), using SPM12. In each condition (placebo & no drug) subjects underwent four sets of pain stimulation at high and low temperatures (somatosensory control condition). The stimuli were modeled as boxcar time series, with additional regressors for temperature ramp-up, ramp-down, pain rating sequence, and six motion regressors.data were collected for each of the two PET-MR scans. Contrasts analyzed included pain stimulation.

    The values for the 8 sets of stimulation, for both the migraine and the healthy group are combined


  3. PET Diprenorphine [ Time Frame: 1 day ]
    We sought to find if endogenous opioid levels and endogenous opioid release induced by placebo administration differentiates between the no intervention first, then placebo group compared to the placebo first, then no intervention group in migraine patients.



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Migraine patients with aura with acute episodic migraine meeting the IHS Classification ICHD-II criteria, 3-14 migraines per month.
  • History of episodic migraine for at least 3 years
  • Ages 21-50
  • Male or Female
  • Right Handed

Matched healthy subjects will also be recruited.

Exclusion Criteria:

  • Other significant disease (systemic or CNS)
  • Pregnancy
  • Claustrophobia
  • Weight >235 lbs (limit of MRI table)
  • Significant drug including alcohol history (> 7 glasses of alcohol per week)
  • Beck Depression Inventory II (BDI-II) score > 25 (moderate to severe depression)
  • Any metal implants incompatible with MRI (including dental bridges, crowns, retainers, orthodontic devices e.g. braces, IUDs, aneurysm clips or other devices, tattoos containing metallic ink, cardiac pacemakers, prosthetic hear valves, other prostheses, neurostimulator devices, implanted infusion pumps, exposure to shrapnel or metal filings, cochlear implants, etc.)
  • Previous significant research related exposure to ionizing radiation.
  • History of allergy or adverse reaction to opioids
  • Significant medical history of such as seizure disorder, diabetes, alcoholism, cardiac disease including coronary artery disease, psychiatric problems; drug addiction, respiratory problems, liver disease, etc.
  • Positive drug of abuse screen (excluding medications currently prescribed for their clinical condition, e.g. opioids, benzodiazepines, etc.)
  • Patients with migraine <72 hours prior to the experiments will not be included to ensure inter-ictal state.
  • Opioids or preventative medication such as topiramate, SSRIs etc.

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): NCT01970943


Locations
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United States, Massachusetts
Athinoula A. Martinos. Center for Biomedical Imaging
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: David Borsook, MD, Ph.D Boston Children’s Hospital

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Responsible Party: David Borsook, David Borosook, MD, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01970943     History of Changes
Other Study ID Numbers: AT007530-01
R21AT007530-01 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2013    Key Record Dates
Results First Posted: May 17, 2019
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Borsook, Mclean Hospital:
migraine, headache, episodic, chronic, pain

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases