Back to resultsMolecular and Functional PET-fMRI Measures of Analgesia in Migraine
Primary Purpose
Migraine, Healthy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Migraine focused on measuring migraine, headache, episodic, chronic, pain
Eligibility 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.
Sites / Locations
- Athinoula A. Martinos. Center for Biomedical Imaging
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Placebo Comparator
Arm Label
No Intervention
Saline Injection (Placebo)
Arm Description
PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition.
PET-fMRI investigation on healthy subjects and patients with migraine. Placebo condition.
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS) 0-10 Pain Rating
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
Pain Anticipation fMRI BOLD Signal
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
Pain Stimulation fMRI BOLD Signal
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
PET Diprenorphine
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.
Full Information
NCT ID
NCT01970943
First Posted
May 23, 2013
Last Updated
May 15, 2019
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01970943
Brief Title
Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
Official Title
Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2012 (Actual)
Primary Completion Date
April 30, 2014 (Actual)
Study Completion Date
October 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Healthy
Keywords
migraine, headache, episodic, chronic, pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition.
Arm Title
Saline Injection (Placebo)
Arm Type
Placebo Comparator
Arm Description
PET-fMRI investigation on healthy subjects and patients with migraine. Placebo condition.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be compared to No Intervention.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) 0-10 Pain Rating
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Pain Anticipation fMRI BOLD Signal
Description
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
Time Frame
1 day
Title
Pain Stimulation fMRI BOLD Signal
Description
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
Time Frame
1 day
Title
PET Diprenorphine
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Borsook, MD, Ph.D
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Athinoula A. Martinos. Center for Biomedical Imaging
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
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Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
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