Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment was severely delayed during COVID, and Grant support ended
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control, Not-Fasting | No Intervention | Participants will experience the control intervention and will not fast prior to the lab visit. | |
| Control, Fasting | Experimental | Participants will experience the control intervention and will fast prior to the lab visit. |
|
| Stress, Not-Fasting | Experimental | Participants will experience the stress intervention and will not fast prior to the lab visit. |
|
| Stress, Fasting | Experimental | Participants will experience the stress intervention and will fast prior to the lab visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress | Behavioral | Trier Social Stress Test |
| |
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Timothy T Houle, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
Not provided
Not provided
Not provided
2 x 2 randomized crossover design
Not provided
Not provided
Not provided
Not provided
| Fasting |
| Other |
12-hour fasting prior to study visit |
|
| 48 hours |
| Pain Scores | Intensity of pain ratings (0 to 10 scale) | 6 hours |
| D009422 | Nervous System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |