Acute Stress Response in Migraine Sufferers

Mass General Brigham

Status: Terminated

Conditions: Migraine Headache

Treatments: Other: Fasting; Behavioral: Stress

Study type: Interventional

Funder types: Other

Identifiers

NCT03099070

2016P001834

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

90 participants in 4 patient groups

Control, Not-Fasting

No Intervention group

Description:

Participants will experience the control intervention and will not fast prior to the lab visit.

Control, Fasting

Experimental group

Description:

Participants will experience the control intervention and will fast prior to the lab visit.

Treatment:

Other: Fasting

Stress, Not-Fasting

Experimental group

Description:

Participants will experience the stress intervention and will not fast prior to the lab visit.

Treatment:

Behavioral: Stress

Stress, Fasting

Experimental group

Description:

Participants will experience the stress intervention and will fast prior to the lab visit.

Treatment:

Behavioral: Stress

Other: Fasting