Migraine HeadacheNCT03099070
Acute Stress Response in Migraine Sufferers
A study testing Stress and Fasting in people with Migraine Headache, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Stress and Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2017to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Migraine Headache
- Being tested
- Stress, Fasting
- Keywords
- Stress, Fasting, Migraine
- Medical subject headings
- Migraine Disorders, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StressBehavioural
Trier Social Stress Test
FastingOther
12-hour fasting prior to study visit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fasting |
| Stress, Not-Fasting | Experimental | Participants will experience the stress intervention and will not fast prior to the lab visit. Receives: Behavioral: Stress |
| Stress, Fasting | Experimental | Participants will experience the stress intervention and will fast prior to the lab visit. Receives: Behavioral: Stress; Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of lab visit (6 hours)
Secondary outcomes (3)
Time to next headache attack
Time-to-event analysis using diary information
Measured: 48 hours
Medication use
Frequency of abortive/analgesic medication use
Measured: 48 hours
Pain Scores
Intensity of pain ratings (0 to 10 scale)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start8 Mar 2017
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Why it stopped: Recruitment was severely delayed during COVID, and Grant support ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2 x 2 randomized crossover design
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Houle, Massachusetts General Hospital
- Investigators
- Timothy T Houle, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099070
- Sponsor's protocol ID
- 2016P001834
- Status last verified
- Aug 2023
- First submitted
- 28 Mar 2017
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Stress Response in Migraine Sufferers
- ClinicalTrials.gov ID
- NCT03099070
- Acronym / sponsor ID
- 2016P001834
- Conditions
- Migraine Headache
- Keywords
- Stress, Fasting, Migraine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was severely delayed during COVID, and Grant support ended
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2 x 2 randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Control, Not-Fasting | No intervention | –Participants will experience the control intervention and will not fast prior to the lab visit. |
| Control, Fasting | Experimental | Other: FastingParticipants will experience the control intervention and will fast prior to the lab visit. |
| Stress, Not-Fasting | Experimental | Behavioral: StressParticipants will experience the stress intervention and will not fast prior to the lab visit. |
| Stress, Fasting | Experimental | Behavioral: Stress, Other: FastingParticipants will experience the stress intervention and will fast prior to the lab visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StressTrier Social Stress Test | Behavioural | Stress, Fasting, Stress, Not-Fasting |
| Fasting12-hour fasting prior to study visit | Other | Control, Fasting, Stress, Fasting |
Primary outcome
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
3 secondary outcomes
Time to next headache attack
Time frame: 48 hours
Medication use
Time frame: 48 hours
Pain Scores
Time frame: 6 hours
Results and safety
The study was stopped early (reason given: Recruitment was severely delayed during COVID, and Grant support ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy T Houle, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress and Fasting in people with Migraine Headache, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was severely delayed during COVID, and Grant support ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache/Medication Use (time frame: Duration of lab visit (6 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.