Acute Stress Response in Migraine Sufferers

Migraine Headache Clinical Trial

Official title:

Acute Stress Response in Migraine Sufferers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03099070
• Other study ID #: 2016P001834
• Status: Terminated
• Phase: N/A
• Start date: March 8, 2017
• Est. completion date: August 15, 2020

Study information

• Verified date: August 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Behavioral:
• Stress
Trier Social Stress Test

Other:
• Fasting
12-hour fasting prior to study visit

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

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