Healthy Control Population for PAIS-ME/CFS: Study to Evaluate Possible Biomarkers and Methods for Examination of PAIS-ME/CFS Diagnostics in Healthy Volunteers

N/ANot Yet RecruitingNCT06653712

Technical University of Munich200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Healthy Controls

Interventions

Diagnostic TestDIAGNOSTIC_TEST

The following clinical data sources are used: * Personal interview (anamnesis) * Physical examination * Questionnaires * Functional assessment * Imaging techniques The following biological materials are used: • Max. 30 ml of blood

Eligibility

Sex: ALLMin age: 10 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy control subjects without a known medical diagnosis, except: asthma, allergies, neurodermatitis, if this does not require regular medication (self-disclosure) * Age: 10 - 25 years * Written declaration of consent or, in the case of minors, written declaration of consent from the participants and their legal representatives Exclusion Criteria: * Acute illnesses (e.g. infections) or major injuries * Known chronic diseases (including psychological diagnoses) other than those mentioned above * Surgery or blood transfusion in the last 3 months * No intake of on-demand medication (e.g. painkillers) in the last 7 days before the date of the examination * Pregnancy; Breastfeeding * Limited legal capacity