Acute Stress Response in Migraine Sufferers

Study Overview
=================
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.

Official Title
-----------------
Acute Stress Response in Migraine Sufferers

Conditions
-----------------
Migraine Headache

Intervention / Treatment
-----------------
* Behavioral: Stress
* Other: Fasting


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 2 x 2 randomized crossover design
Masking: None (Open Label)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress, Fasting, Migraine