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Acute Stress Response in Migraine Sufferers

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ClinicalTrials.gov Identifier: NCT03099070
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will examine the influence of stress and fasting on headache activity. Participants will receive both a control and stress session and be randomized to either fasting or not fasting for the visits.

Condition or disease Intervention/treatment
Migraine Headache Behavioral: Stress Other: Fasting

Detailed Description:

Stress and headache are intricately interrelated. Stress is thought to contribute to headache disorder onset in predisposed individuals, trigger or worsen individual headache episodes in those with headache, and exacerbate the progression of a headache disorder. In exacerbating headache disorder progression, stress is believed to be a major factor in headache transformation from an episodic to a chronic condition.

Broadly stated, stress is conceptualized as an imbalance between a demand, whether actual or perceived, and resources to handle the demand, resulting in a strain on the system. A stressor is any challenge or threat, whether objectively verified or not, to normal functioning. The stress response is the body's activation of physiological systems to protect and restore functioning.

This study is 2 x 2 experiment using male and female migraine sufferers. Participants will be randomized to a fasting or not fasting condition for the visits. Thus, the experiment is a 2 (control versus stress) x 2 (fasting versus not). During the approximately 4 weeks of participation (ranging from 9 to a maximum of 28 days), a participant also will complete a twice-daily diary.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2 x 2 randomized crossover design
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acute Stress Response in Migraine Sufferers
Actual Study Start Date : March 8, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control, Not-Fasting
Participants will experience the control intervention and will not fast prior to the lab visit.
Experimental: Control, Fasting
Participants will experience the control intervention and will fast prior to the lab visit.
Other: Fasting
12-hour fasting prior to study visit
Experimental: Stress, Not-Fasting
Participants will experience the stress intervention and will not fast prior to the lab visit.
Behavioral: Stress
Trier Social Stress Test
Experimental: Stress, Fasting
Participants will experience the stress intervention and will fast prior to the lab visit.
Behavioral: Stress
Trier Social Stress Test
Other: Fasting
12-hour fasting prior to study visit


Outcome Measures

Primary Outcome Measures :
  1. Headache/Medication Use [ Time Frame: Duration of lab visit (6 hours) ]
    The presence of a headache attack that is >= 4/10 on a 0 to 10 scale or a headache attack that requires the use of abortive/analgesic medication


Secondary Outcome Measures :
  1. Time to next headache attack [ Time Frame: 48 hours ]
    Time-to-event analysis using diary information

  2. Medication use [ Time Frame: 48 hours ]
    Frequency of abortive/analgesic medication use

  3. Pain Scores [ Time Frame: 6 hours ]
    Intensity of pain ratings (0 to 10 scale)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women and men 18-65 years of age
  • A provisional diagnosis of migraine (with or without aura).
  • Headache frequency of 2 to 15 attacks/month

Exclusion Criteria:

  • Presence of a secondary headache disorder (e.g., brain tumor)
  • Chronic daily headache (> 15 headache days/month) or medication over-use headache (> 8 abortive medication doses/month)
  • Recent change in nature of headache symptoms over last 6 weeks
  • Not being able to read or speak English at a 6th grade level
  • Any condition that would preclude the safe experience of a benign laboratory stressor including seizure disorder, Axis-I psychotic disorder, unstable cardiac conditions
  • An active substance dependence issue (e.g., alcohol, marijuana) that interferes with data collection and headache activity.
Contacts and Locations

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): NCT03099070


Contacts
Contact: Timothy T Houle, PhD thoule1@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Timothy T Houle, PhD       thoule1@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Timothy T Houle, PhD Massachusetts General Hospital
More Information

Responsible Party: Timothy Houle, Associate Scientist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03099070     History of Changes
Other Study ID Numbers: 2016P001834
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Timothy Houle, Massachusetts General Hospital:
Stress
Fasting
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms