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Completed

NCT Number: NCT04949204

Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache

This is an observational, longitudinal cohort pilot study measuring physiological signals through wearable sensors combined with machine learning algorithms to detect behaviour, stress and headaches in patients with migraine and cluster headache.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Ghent: Department of Neurology

Ghent, 9000, Belgium

About this study

Migraine and cluster headache are among the most disabling headache conditions in humans. Both conditions have different phases such as the prodromal/premonitory phase, the aura phase, the headache phase and the postdromal phase. This pilot study examines the potential of wearable sensors combined with machine learning algorithms to investigate the biological changes over time in both conditions. Behaviour such as movement, sleep and activity will be monitored. Stress levels will be estimated through the wearable data combined with input from the patients. Participants will use a wearable device around the wrist and self-developed headache application for 21 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • migraine or cluster headache diagnosis based on ICHD 3 criteria
  • at least 2 attacks each month
  • onset of headache syndrome before the age of 50
  • if multiple headache syndromes coexist: attacks are clearly distinguishable
  • participant has smartphone that he/she wants to apply for this research

Exclusion criteria

  • chronic migraine patients
  • history of alcohol or illicit drug abuse
  • significant medical comorbidity deemed by the investigator to interfere with the study
  • use of betablockers
  • participating in other academic or commercial trials

Treatment and study plan

Wearable sensor detection

Procedure

Empatica E4 wearable wrist sensor

Primary outcomes

  1. Galvanic Skin Response changes

    Time frame: 21 days

    Changes in GSR through the different phases of the headache attacks

Secondary outcomes

  1. Activity ratio

    Time frame: 21 days

    Activity ratio measurement through accelerometer data

  2. Skin temperature

    Time frame: 21 days

    Skin temperature measurement through builtin thermometer

Other outcomes

  1. Prevalence of premonitory symptoms

    Time frame: 21 days

  2. Prevalence of cranial autonomic symptoms

    Time frame: 21 days

  3. Prevalence of postdromal symptoms

    Time frame: 21 days

  4. MSQv2.1 questionnaire

    Time frame: 21 days

    In migraine patients

  5. MIDAS questionnaire

    Time frame: 21 days

    In migraine patients

  6. SF20

    Time frame: 21 days

    In migraine and cluster headache patients

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

Contextuele Analyse, Fysiologische Metingen en Machinaal Leren Voor Migraine en Clusterhoofdpijn (COPIMAC Studie)

Acronym: COPIMAC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2021
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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