NCT04949204

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

December 5, 2022

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

June 24, 2021

Last Update Submit

December 2, 2022

Conditions

MigraineCluster Headache

Outcome Measures

Primary Outcomes (1)

  • Galvanic Skin Response changes

    Changes in GSR through the different phases of the headache attacks

    21 days

Secondary Outcomes (2)

  • Activity ratio

    21 days

  • Skin temperature

    21 days

Other Outcomes (6)

  • Prevalence of premonitory symptoms

    21 days

  • Prevalence of cranial autonomic symptoms

    21 days

  • Prevalence of postdromal symptoms

    21 days

  • +3 more other outcomes

Study Arms (2)

Migraine patients

Wearable wrist sensor + headache application on smartphone

Procedure: Wearable sensor detection

Cluster Headache Patients

Wearable wrist sensor + headache application on smartphone

Procedure: Wearable sensor detection

Interventions

Wearable sensor detectionPROCEDURE

Empatica E4 wearable wrist sensor

Cluster Headache PatientsMigraine patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Migraine or cluster headache patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Ghent: Department of Neurology

Ghent, 9000, Belgium

Location

Related Publications (2)

  • Vandenbussche N, Van Der Donckt J, De Brouwer M, Steenwinckel B, Stojchevska M, Ongenae F, Van Hoecke S, Paemeleire K. Patients with chronic cluster headache may show reduced activity energy expenditure on ambulatory wrist actigraphy recordings during daytime attacks. Brain Behav. 2024 Jan;14(1):e3360. doi: 10.1002/brb3.3360.

    PMID: 38376015DERIVED

  • De Brouwer M, Vandenbussche N, Steenwinckel B, Stojchevska M, Van Der Donckt J, Degraeve V, Vaneessen J, De Turck F, Volckaert B, Boon P, Paemeleire K, Van Hoecke S, Ongenae F. mBrain: towards the continuous follow-up and headache classification of primary headache disorder patients. BMC Med Inform Decis Mak. 2022 Mar 31;22(1):87. doi: 10.1186/s12911-022-01813-w.

    PMID: 35361224DERIVED

MeSH Terms

Conditions

Migraine DisordersCluster Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrigeminal Autonomic Cephalalgias

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 2, 2021

Study Start

July 1, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

December 5, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)