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

NCT ID: NCT06653712

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2029-12-31

Brief 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.

Detailed 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.

Conditions

Healthy Controls

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy controls

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

Diagnostic Test

Intervention Type: DIAGNOSTIC_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

Interventions

Diagnostic 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Max-Planck Institut

UNKNOWN

Sponsor Role: collaborator

University Hospital Erlangen

OTHER

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Prof. Dr. med. Uta Behrends

Role: CONTACT

uta.behrends@mri.tum.de

+49 89 3068 2793

Other Identifiers

HelP

Identifier Type: -

Identifier Source: org_study_id