Acute Stress Response in Migraine Sufferers

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.

Study Overview

• Status: Terminated
• Conditions: Migraine Headache
• Intervention / Treatment: Other: Fasting; Behavioral: Stress

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.	Other: Fasting; 12-hour fasting prior to study visit; Behavioral: Stress; Trier Social Stress Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache/Medication Use	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	Duration of lab visit (6 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to next headache attack	Time-to-event analysis using diary information	48 hours
Medication use	Frequency of abortive/analgesic medication use	48 hours
Pain Scores	Intensity of pain ratings (0 to 10 scale)	6 hours

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Timothy T Houle, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Stress; Migraine; Fasting
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: 2016P001834

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No