Acute Stress Response in Migraine Sufferers
Primary Purpose
Migraine Headache
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress
Fasting
Sponsored by
About this trial
This is an interventional basic science trial for Migraine Headache focused on measuring Stress, Fasting, Migraine
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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control, Not-Fasting
Control, Fasting
Stress, Not-Fasting
Stress, Fasting
Arm Description
Participants will experience the control intervention and will not fast prior to the lab visit.
Participants will experience the control intervention and will fast prior to the lab visit.
Participants will experience the stress intervention and will not fast prior to the lab visit.
Participants will experience the stress intervention and will fast prior to the lab visit.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to next headache attack
Time-to-event analysis using diary information
Medication use
Frequency of abortive/analgesic medication use
Pain Scores
Intensity of pain ratings (0 to 10 scale)
Full Information
NCT ID
NCT03099070
First Posted
March 28, 2017
Last Updated
August 21, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03099070
Brief Title
Acute Stress Response in Migraine Sufferers
Official Title
Acute Stress Response in Migraine Sufferers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was severely delayed during COVID, and Grant support ended
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
Stress, Fasting, Migraine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
2 x 2 randomized crossover design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control, Not-Fasting
Arm Type
No Intervention
Arm Description
Participants will experience the control intervention and will not fast prior to the lab visit.
Arm Title
Control, Fasting
Arm Type
Experimental
Arm Description
Participants will experience the control intervention and will fast prior to the lab visit.
Arm Title
Stress, Not-Fasting
Arm Type
Experimental
Arm Description
Participants will experience the stress intervention and will not fast prior to the lab visit.
Arm Title
Stress, Fasting
Arm Type
Experimental
Arm Description
Participants will experience the stress intervention and will fast prior to the lab visit.
Intervention Type
Behavioral
Intervention Name(s)
Stress
Intervention Description
Trier Social Stress Test
Intervention Type
Other
Intervention Name(s)
Fasting
Intervention Description
12-hour fasting prior to study visit
Primary Outcome Measure Information:
Title
Headache/Medication Use
Description
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 Frame
Duration of lab visit (6 hours)
Secondary Outcome Measure Information:
Title
Time to next headache attack
Description
Time-to-event analysis using diary information
Time Frame
48 hours
Title
Medication use
Description
Frequency of abortive/analgesic medication use
Time Frame
48 hours
Title
Pain Scores
Description
Intensity of pain ratings (0 to 10 scale)
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy T Houle, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute Stress Response in Migraine Sufferers
We'll reach out to this number within 24 hrs