NCT06825741

Brief Summary

Introduction: The clinical manifestations of the COVID-19 pandemic are heterogeneous and may include various symptoms (gastrointestinal, musculoskeletal, neurological). Approximately 25% of patients report headache as a neurological symptom, making it the fifth most common symptom. These headaches may arise from structural brain changes associated with the infection. Purpose: This study aims to identify the structural abnormalities observed in brain MRI that correlate with chronic headaches in patients who had COVID-19 infection. Methods: The study included 30 patients with post-COVID-19 headaches and 30 control patients with no history of COVID-19. Demographic characteristics were analyzed using t-tests and chi-square tests. MRI findings were categorized into six types: cortical atrophy, white matter lesions, vascular lesions, lacunar lesions, vascular encephalopathy, and sinusitis. Differences in MRI findings between the two groups were evaluated using chi-square tests. Secondary outcomes included the analysis of symptoms accompanying headaches, diagnoses following MRI, and treatments applied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

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

September 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

February 11, 2025

Last Update Submit

February 13, 2025

Conditions

Keywords

COVID-19headacheMRIbrainwhite matter lesion

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Specific Structural Brain Abnormalities Observed on MRI

    Brain MRI scans were analyzed to determine the number of participants with specific structural abnormalities, including white matter lesions, cortical atrophy, vascular encephalopathy, lacunar infarcts, and sinusitis. Each abnormality was evaluated separately, and the number of participants affected by each type was recorded.

    From September 2020 to December 2022

Secondary Outcomes (3)

  • Number of Participants Reporting Additional Symptoms Associated with Post-COVID-19 Headache

    From September 2020 to December 2022

  • Number of Participants Diagnosed with Specific Conditions After MRI

    From September 2020 to December 2022

  • Number of Participants Receiving Specific Treatment Approaches for Post-COVID-19 Headache

    From September 2020 to December 2022

Study Arms (2)

Post-COVID-19 Headache Group

Participants in this group had a history of COVID-19 infection and developed persistent headaches afterward. They underwent brain MRI to assess potential structural abnormalities. Exclusion criteria included pre-existing neurological disorders or other conditions that could explain the headaches.

Other: Observational Study - No intervention

Control Group

Participants in this group had no history of COVID-19 infection and no reported chronic headaches or neurological conditions. They underwent brain MRI for unrelated medical reasons and served as a comparison group to evaluate the prevalence of structural brain abnormalities in post-COVID headache patients.

Other: Observational Study - No intervention

Interventions

This is an observational study evaluating brain structural abnormalities in post-COVID headache patients. No experimental intervention is applied.

Control GroupPost-COVID-19 Headache Group

Eligibility Criteria

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

The study population consisted of adult patients (≥18 years) with persistent headaches following COVID-19 infection who were referred for brain MRI to investigate potential structural abnormalities. A control group of individuals without a history of COVID-19 infection or chronic headaches was included for comparison. Exclusion criteria included prior neurological diseases, recent head trauma, and MRI contraindications.

You may qualify if:

  • Age ≥18 years
  • History of COVID-19 infection
  • Persistent headache following COVID-19 infection
  • Brain MRI requested by the attending physician

You may not qualify if:

  • Prior neurological disease or disorder
  • MRI contraindications (e.g., pacemaker, metal implants, claustrophobia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Szent Margit Hospital

Budapest, 1032, Hungary

Location

Related Publications (1)

  • Szephelyi K, Kora S, Orsi G, Tollar J. Brain Structural Abnormalities in Patients with Post-COVID-19 Headache. Neurol Int. 2025 Mar 26;17(4):50. doi: 10.3390/neurolint17040050.

MeSH Terms

Conditions

COVID-19Headache

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 13, 2025

Study Start

September 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Locations