Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

NCT01970943 | Completed Results

• 2 other identifiers: AT007530-01R21AT007530-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Healthy

Keywords

migraine, headache, episodic, chronic, pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain Anticipation fMRI BOLD Signal

  1 day

• Pain Stimulation fMRI BOLD Signal

  1 day

• PET Diprenorphine

  1 day

Study Arms (2)

No Intervention

NO INTERVENTION

PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition.

Saline Injection (Placebo)

PLACEBO COMPARATOR

PET-fMRI investigation on healthy subjects and patients with migraine. Placebo condition.

Other: Placebo

Interventions

Placebo OTHER

Placebo will be compared to No Intervention.

Saline Injection (Placebo)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Athinoula A. Martinos. Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache; Recurrence; Bronchiolitis Obliterans Syndrome; Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr David Borsook, study PI
• Organization: Massachusetts General Hospital

david.borsook@childrens.harvard.edu

6172817135

Study Officials

• David Borsook, MD, Ph.D

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David Borosook, MD

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: October 28, 2013
• Study Start: September 1, 2012
• Primary Completion: April 30, 2014
• Study Completion: October 30, 2017
• Last Updated: May 17, 2019
• Results First Posted: May 17, 2019

Record last verified: 2019-05

Locations

US (1)