Skip to main content
OpenTrials
Completed

NCT Number: NCT01970943

Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Migraine Brain Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Central Nervous System Diseases Disease Attributes Graft vs Host Disease Headache Headache Disorders Headache Disorders, Primary Healthy Immune System Diseases Lung Diseases Lung Diseases, Obstructive Migraine Disorders Nervous System Diseases Neurologic Manifestations Organizing Pneumonia Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases Signs and Symptoms

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athinoula A. Martinos. Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Other

Placebo will be compared to No Intervention.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Oct 28, 2013
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.