Clinical trial NCT03099070: Acute Stress Response in Migraine Sufferers
Official title: Acute Stress Response in Migraine Sufferers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Migraine Headache
Keywords: Stress
Fasting
Migraine
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 x 2 randomized crossover design
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Headache/Medication Use
timeFrame: Duration of lab visit (6 hours)
Secondary outcomes:
measure: Time to next headache attack
timeFrame: 48 hours
measure: Medication use
timeFrame: 48 hours
measure: Pain Scores
timeFrame: 6 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Timothy T Houle, PhD
role: PRINCIPAL_INVESTIGATOR
References: