Migraine Headache
Conditions
Keywords
Stress, Fasting, Migraine
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.
Interventions
BEHAVIORALStress
Trier Social Stress Test
OTHERFasting
12-hour fasting prior to study visit
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
2 x 2 randomized crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to next headache attack | 48 hours | Time-to-event analysis using diary information |
| Medication use | 48 hours | Frequency of abortive/analgesic medication use |
| Pain Scores | 6 hours | Intensity of pain ratings (0 to 10 scale) |
Countries
United States
Outcome results
None listed