Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
| Max-Planck Institut | UNKNOWN |
| University Hospital Erlangen | OTHER |
Not provided
Not provided
Not provided
Not provided
Using the data from the HelP study, the underlying processes of the diseases ME/CFS and PAIS are to be researched and elucidated. The comparison of affected patients with healthy controls is intended to identify disease-specific patterns that could be related to the development or progression of the disease. The aim is to find a suitable biomarker for diagnostics and to develop therapeutic approaches.
The underlying pathomechanisms of the diseases PAIS and ME/CFS are to be investigated and elucidated in more detail. The aim is to establish a cohort of healthy controls at our MRI Chronic Fatigue Center (MCFC). Within this cohort, the measurement instruments used so far in ME/CFS diagnostics will be validated. In addition, data material from this pool should be used for the statistical evaluations of various case-control studies of our center and our cooperation partners in order to find and develop a suitable biomarker for diagnostics and therapeutic approaches for PAIS and ME/CFS.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy controls | Healthy participants between 10 and 25 years of age. We plan to recruit 5 to 10 participants per age group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test | Diagnostic Test | The following clinical data sources are used:
The following biological materials are used: • Max. 30 ml of blood |
| Measure | Description | Time Frame |
|---|---|---|
| Personal data | Name, date of birth, contact details | Measurement is taken at a single time point right after enrollment |
| Clinical data | Sex, vaccination status, level of education, occupation, smoking and alcohol behavior, other addictive behavior, competitive sports | Measurement is taken at a single time point right after enrollment |
| Physical assessment | weight and height will be combined to report BMI in kg/m^2 | Measurement is taken at a single time point right after enrollment |
| Heart rate | beats per minute | Measurement is taken at a single time point right after enrollment |
| Blood pressure | in mmHg | Measurement is taken at a single time point right after enrollment |
| Questionnaire data | Following questionnaires are rated on a scale: MBSQ, Chalder Fatigue Scale, PedsQL Fatigue, Bell Score, DSQ-PEM, SF-36, PedsQL, EQ5D, PHQ4, Compass31 | Measurement is taken at a single time point right after enrollment |
| YSR questionnaire | Open questions and questions to be rated on a scale | Measurement is taken at a single time point right after enrollment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Healthy controls are recruited via public relations
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. med. Uta Behrends | Contact | +49 89 3068 2793 | uta.behrends@mri.tum.de |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples
| Imaging |
OCT-A: Imaging of ocular fundus |
| Measurement is taken at a single time point right after enrollment |
| Full blood count | CRP, Ferritin, Creatinin, GPT and Immunglobuline | Measurement is taken at a single time point right after enrollment |
| Deformability Cytometer | Cell-deformation | Measurement is taken at a single time point right after enrollment |
| Virology | EBV, CMV, HSV1, HSV2 and Sars CoV2 antibodies | Measurement is taken at a single time point right after enrollment |
| Immunology | ANA, Cystatin C, dsDNA Ak | Measurement is taken at a single time point right after enrollment |
| Endocrinology | TPO antibodies | Measurement is taken at a single time point right after enrollment |
| B-cell phenotyping | Analysis of surface antigens using cytometry by time of flights (CyTOF) | Measurement is taken at a single time point right after enrollment |
| Pain threshold | Measuring pressure tolerancy in Newton by means of an algometer at the iliotibial tract, phalanx distalis III, trapezius muscle in triplicates | Measurement is taken at a single time point right after enrollment |
| Orthostasic Tolerance | blood pressure and heart rate are measured during the 10-minute standing test to determine orthostasic tolerance | Measurement is taken at a single time point right after enrollment |
| Grip strength | Hand dynamometer test to assess grip strength in Newton | Measurement is taken at a single time point right after enrollment |
| Smell test | Recognition of different substances | Measurement is taken at a single time point right after enrollment |
| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003955 | Diagnostic Tests, Routine |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided