---
title: Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
nct_id: NCT04949204
overall_status: COMPLETED
sponsor: University Hospital, Ghent
study_type: OBSERVATIONAL
primary_condition: Migraine
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04949204.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04949204"
ct_last_update_post_date: 2022-12-05
last_seen_at: "2026-05-12T06:41:08.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache

**Official Title:** Contextuele Analyse, Fysiologische Metingen en Machinaal Leren Voor Migraine en Clusterhoofdpijn (COPIMAC Studie)

**NCT ID:** [NCT04949204](https://clinicaltrials.gov/study/NCT04949204)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 19
- **Lead Sponsor:** University Hospital, Ghent
- **Collaborators:** University Ghent
- **Conditions:** Migraine, Cluster Headache
- **Start Date:** 2020-07-01
- **Completion Date:** 2021-07-31
- **CT.gov Last Update:** 2022-12-05

## 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.

## Detailed Description

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Migraine patients** — Wearable wrist sensor + headache application on smartphone
- **Cluster Headache Patients** — Wearable wrist sensor + headache application on smartphone

## Interventions

- **Wearable sensor detection** (PROCEDURE) — Empatica E4 wearable wrist sensor

## Primary Outcomes

- **Galvanic Skin Response changes** _(time frame: 21 days)_ — Changes in GSR through the different phases of the headache attacks

## Secondary Outcomes

- **Activity ratio** _(time frame: 21 days)_
- **Skin temperature** _(time frame: 21 days)_

## Locations (1)

- University Hospital, Ghent: Department of Neurology, Ghent, Belgium

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university hospital, ghent: department of neurology|ghent||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04949204.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04949204*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*