Not Yet RecruitingNot Applicable

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

200 participantsStarted 2024-10

Plain-language summary

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.

Who can participate

Age range10 Years – 25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Personal data

Timeframe: Measurement is taken at a single time point right after enrollment

Clinical data

Timeframe: Measurement is taken at a single time point right after enrollment

Physical assessment

Timeframe: Measurement is taken at a single time point right after enrollment

Heart rate

Timeframe: Measurement is taken at a single time point right after enrollment

Blood pressure

Timeframe: Measurement is taken at a single time point right after enrollment

Questionnaire data

Timeframe: Measurement is taken at a single time point right after enrollment

YSR questionnaire

Timeframe: Measurement is taken at a single time point right after enrollment

Imaging

Timeframe: Measurement is taken at a single time point right after enrollment

Trial details

NCT IDNCT06653712

SponsorTechnical University of Munich

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-12

Contact for this trial

Prof. Dr. med. Uta Behrends

+49 89 3068 2793 uta.behrends@mri.tum.de

View on ClinicalTrials.gov More Healthy Controls trials

Plain-language summary

Who can participate

Age range10 Years – 25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Personal data

Timeframe: Measurement is taken at a single time point right after enrollment

Clinical data

Timeframe: Measurement is taken at a single time point right after enrollment

Physical assessment

Timeframe: Measurement is taken at a single time point right after enrollment

Heart rate

Timeframe: Measurement is taken at a single time point right after enrollment

Blood pressure

Timeframe: Measurement is taken at a single time point right after enrollment

Questionnaire data

Timeframe: Measurement is taken at a single time point right after enrollment

YSR questionnaire

Timeframe: Measurement is taken at a single time point right after enrollment

Imaging

Timeframe: Measurement is taken at a single time point right after enrollment