Acute Stress Response in Migraine Sufferers

NCT03099070 | Terminated

• 1 other identifier: 2016P001834
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Headache

Keywords

Stress; Fasting; Migraine

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Time to next headache attack

  48 hours

• Medication use

  48 hours

• Pain Scores

  6 hours

Study Arms (4)

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.

Other: Fasting

Stress, Not-Fasting

EXPERIMENTAL

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

Behavioral: Stress

Stress, Fasting

EXPERIMENTAL

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

Behavioral: Stress; Other: Fasting

Interventions

Stress BEHAVIORAL

Trier Social Stress Test

Stress, Fasting; Stress, Not-Fasting

Fasting OTHER

12-hour fasting prior to study visit

Control, Fasting; Stress, Fasting

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Feeding Behavior; Behavior

Study Officials

• Timothy T Houle, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Model Details: 2 x 2 randomized crossover design

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: March 8, 2017
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)