Clinical trial NCT06825741: Brain Structural Abnormalities in Patients with Post-COVID-19 Headache
Official title: Brain Structural Abnormalities in Patients with Post-COVID-19 Headache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Headache
MRI
Keywords: COVID-19
headache
MRI
brain
white matter lesion
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants with Specific Structural Brain Abnormalities Observed on MRI
timeFrame: From September 2020 to December 2022
Secondary outcomes:
measure: Number of Participants Reporting Additional Symptoms Associated with Post-COVID-19 Headache
timeFrame: From September 2020 to December 2022
measure: Number of Participants Diagnosed with Specific Conditions After MRI
timeFrame: From September 2020 to December 2022
measure: Number of Participants Receiving Specific Treatment Approaches for Post-COVID-19 Headache
timeFrame: From September 2020 to December 2022
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Szent Margit Hospital
Study officials:
References: