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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
2 x 2 randomized crossover design
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Control, Not-Fasting 		Participants will experience the control intervention and will not fast prior to the lab visit.
Experimental
Control, Fasting 		Participants will experience the control intervention and will fast prior to the lab visit.
  • Other: Fasting
    12-hour fasting prior to study visit
Experimental
Stress, Not-Fasting 		Participants will experience the stress intervention and will not fast prior to the lab visit.
  • Behavioral: Stress
    Trier Social Stress Test
Experimental
Stress, Fasting 		Participants will experience the stress intervention and will fast prior to the lab visit.
  • Behavioral: Stress
    Trier Social Stress Test
  • Other: Fasting
    12-hour fasting prior to study visit

More Details

Status
Terminated
Sponsor
Massachusetts General Hospital

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.