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

Technical University of Munich

Status: Not yet enrolling

Conditions: Healthy Controls

Treatments: Diagnostic Test: Diagnostic Test

Study type: Observational

Funder types: Other

Identifiers

NCT06653712

HelP

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 10 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Healthy controls

Description:

Healthy participants between 10 and 25 years of age. We plan to recruit 5 to 10 participants per age group.

Treatment:

Diagnostic Test: Diagnostic Test