Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

Healthy Clinical Trial

Official title:

Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970943
• Other study ID #: AT007530-01
• Secondary ID: R21AT007530-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2012
• Est. completion date: October 30, 2017

Study information

• Verified date: May 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 30, 2017
• Est. primary completion date: April 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Migraine
• Migraine Disorders

Intervention

Other:
• Placebo
Placebo will be compared to No Intervention.

Locations

Country	Name	City	State
United States	Athinoula A. Martinos. Center for Biomedical Imaging	Charlestown	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	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	1 day
Secondary	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	1 day
Secondary	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.	1 day