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 range

10 Years – 25 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

10 Years – 25 Years

Sex

ALL

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