- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06825741
Brain Structural Abnormalities in Patients with Post-COVID-19 Headache
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Budapest, Hungary, 1032
- Szent Margit Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
This is an observational study evaluating brain structural abnormalities in post-COVID headache patients.
No experimental intervention is applied.
|
|
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.
|
This is an observational study evaluating brain structural abnormalities in post-COVID headache patients.
No experimental intervention is applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants with Specific Structural Brain Abnormalities Observed on MRI
Time Frame: From September 2020 to December 2022
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Reporting Additional Symptoms Associated with Post-COVID-19 Headache
Time Frame: From September 2020 to December 2022
|
The number of participants experiencing symptoms such as dizziness, cognitive dysfunction, and visual disturbances was recorded.
Each symptom was assessed separately and reported as the number of affected participants.
|
From September 2020 to December 2022
|
|
Number of Participants Diagnosed with Specific Conditions After MRI
Time Frame: From September 2020 to December 2022
|
Following MRI evaluation, the number of participants diagnosed with specific conditions (e.g., migraines, post-COVID headache, vestibular syndrome) was recorded.
Each diagnosis was evaluated and reported separately.
|
From September 2020 to December 2022
|
|
Number of Participants Receiving Specific Treatment Approaches for Post-COVID-19 Headache
Time Frame: From September 2020 to December 2022
|
The number of participants receiving pharmacological treatments (e.g., cognitive enhancers, antidepressants) and lifestyle modifications was recorded.
Each treatment approach was assessed separately and reported as the number of affected participants.
|
From September 2020 to December 2022
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IG/296-1/2025/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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