Acute Stress Response in Migraine Sufferers
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|ClinicalTrials.gov Identifier: NCT03099070|
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Behavioral: Stress Other: Fasting||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||212 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||2 x 2 randomized crossover design|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Acute Stress Response in Migraine Sufferers|
|Actual Study Start Date :||March 8, 2017|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||May 31, 2020|
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.
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.
Trier Social Stress Test
Experimental: Stress, Fasting
Participants will experience the stress intervention and will fast prior to the lab visit.
Trier Social Stress TestOther: Fasting
12-hour fasting prior to study visit
- Headache/Medication Use [ Time Frame: 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
- Time to next headache attack [ Time Frame: 48 hours ]Time-to-event analysis using diary information
- Medication use [ Time Frame: 48 hours ]Frequency of abortive/analgesic medication use
- Pain Scores [ Time Frame: 6 hours ]Intensity of pain ratings (0 to 10 scale)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099070
|Contact: Timothy T Houle, PhDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Timothy T Houle, PhD firstname.lastname@example.org|
|Principal Investigator:||Timothy T Houle, PhD||Massachusetts General Hospital|