Acute Stress Response in Migraine Sufferers

Not Applicable

Terminated

• Conditions: Migraine Headache
• Interventions: Behavioral: Stress; Other: Fasting

• Registration Number: NCT03099070
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study Start: 2017-03-08
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Stress, Fasting	Fasting	Participants will experience the stress intervention and will fast prior to the lab visit.
Control, Fasting	Fasting	Participants will experience the control intervention and will fast prior to the lab visit.
Stress, Not-Fasting	Stress	Participants will experience the stress intervention and will not fast prior to the lab visit.
Stress, Fasting	Stress	Participants will experience the stress intervention and will fast prior to the lab visit.

Primary Outcome Measures

Name	Time	Method
Headache/Medication Use	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

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States