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)

Healthy Control Population für PAIS-ME/CFS: Studie Zur Evaluation möglicher Biomarker Und Untersuchungsmethoden für Die PAIS-ME/CFS-Diagnostik Bei Gesunden Probanden

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Controls
• Intervention / Treatment: Diagnostic test: Diagnostic Test

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Prof. Dr. med. Uta Behrends; Phone Number: +49 89 3068 2793; Email: uta.behrends@mri.tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy controls are recruited via public relations

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls; Healthy participants between 10 and 25 years of age. We plan to recruit 5 to 10 participants per age group.	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal data	Name, date of birth, contact details	Measurement is taken at a single time point right after enrollment
Clinical data	Sex, vaccination status, level of education, occupation, smoking and alcohol behavior, other addictive behavior, competitive sports	Measurement is taken at a single time point right after enrollment
Physical assessment	weight and height will be combined to report BMI in kg/m^2	Measurement is taken at a single time point right after enrollment
Heart rate	beats per minute	Measurement is taken at a single time point right after enrollment
Blood pressure	in mmHg	Measurement is taken at a single time point right after enrollment
Questionnaire data	Following questionnaires are rated on a scale: MBSQ, Chalder Fatigue Scale, PedsQL Fatigue, Bell Score, DSQ-PEM, SF-36, PedsQL, EQ5D, PHQ4, Compass31	Measurement is taken at a single time point right after enrollment
YSR questionnaire	Open questions and questions to be rated on a scale	Measurement is taken at a single time point right after enrollment
Imaging	OCT-A: Imaging of ocular fundus	Measurement is taken at a single time point right after enrollment
Full blood count	CRP, Ferritin, Creatinin, GPT and Immunglobuline	Measurement is taken at a single time point right after enrollment
Deformability Cytometer	Cell-deformation	Measurement is taken at a single time point right after enrollment
Virology	EBV, CMV, HSV1, HSV2 and Sars CoV2 antibodies	Measurement is taken at a single time point right after enrollment
Immunology	ANA, Cystatin C, dsDNA Ak	Measurement is taken at a single time point right after enrollment
Endocrinology	TPO antibodies	Measurement is taken at a single time point right after enrollment
B-cell phenotyping	Analysis of surface antigens using cytometry by time of flights (CyTOF)	Measurement is taken at a single time point right after enrollment
Pain threshold	Measuring pressure tolerancy in Newton by means of an algometer at the iliotibial tract, phalanx distalis III, trapezius muscle in triplicates	Measurement is taken at a single time point right after enrollment
Orthostasic Tolerance	blood pressure and heart rate are measured during the 10-minute standing test to determine orthostasic tolerance	Measurement is taken at a single time point right after enrollment
Grip strength	Hand dynamometer test to assess grip strength in Newton	Measurement is taken at a single time point right after enrollment
Smell test	Recognition of different substances	Measurement is taken at a single time point right after enrollment

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Charite University, Berlin, Germany; University Hospital Erlangen; Max-Planck Institut

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 20, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Biomarker; ME/CFS; Post-Covid
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Encephalomyelitis; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Fatigue Syndrome, Chronic
• Other Study ID Numbers: HelP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No