COVID-19NCT06825741
Brain Structural Abnormalities in Patients with Post-COVID-19 Headache
An observational study of COVID-19 and Headache, run by University of Pecs at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 60 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years
- History of COVID-19 infection
- Persistent headache following COVID-19 infection
- Brain MRI requested by the attending physician
Who cannot join
- Prior neurological disease or disorder
- MRI contraindications (e.g., pacemaker, metal implants, claustrophobia)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Observational Study - No intervention
- Keywords
- COVID-19, headache, MRI, brain, white matter lesion
- Medical subject headings
- COVID-19, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Study - No interventionOther
This is an observational study evaluating brain structural abnormalities in post-COVID headache patients. No experimental intervention is applied.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Observational Study - No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From September 2020 to December 2022
Secondary outcomes (3)
Number of Participants Reporting Additional Symptoms Associated with Post-COVID-19 Headache
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.
Measured: From September 2020 to December 2022
Number of Participants Diagnosed with Specific Conditions After MRI
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.
Measured: From September 2020 to December 2022
Number of Participants Receiving Specific Treatment Approaches for Post-COVID-19 Headache
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.
Measured: From September 2020 to December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Sep 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825741
- Sponsor's protocol ID
- IG/296-1/2025/1
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40278421
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Structural Abnormalities in Patients with Post-COVID-19 Headache
- ClinicalTrials.gov ID
- NCT06825741
- Acronym / sponsor ID
- IG/296-1/2025/1
- Keywords
- COVID-19, headache, MRI, brain, white matter lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-COVID-19 Headache Group | – | Other: Observational Study - No interventionParticipants 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. |
| Control Group | – | Other: Observational Study - No interventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥18 years
- History of COVID-19 infection
- Persistent headache following COVID-19 infection
- Brain MRI requested by the attending physician
Key exclusion criteria (2 listed)
- Prior neurological disease or disorder
- MRI contraindications (e.g., pacemaker, metal implants, claustrophobia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study - No interventionThis is an observational study evaluating brain structural abnormalities in post-COVID headache patients. No experimental intervention is applied. | Other | Control Group, Post-COVID-19 Headache Group |
Primary outcome
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.
3 secondary outcomes
Number of Participants Reporting Additional Symptoms Associated with Post-COVID-19 Headache
Time frame: From September 2020 to December 2022
Number of Participants Diagnosed with Specific Conditions After MRI
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 40278421Szephelyi 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Headache, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Specific Structural Brain Abnormalities Observed on MRI (time frame: From September 2020 to December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06825741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.