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NCT Number: NCT06653712

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

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.

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Key information

Conditions

Healthy Controls Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Personal data

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

    Name, date of birth, contact details

  2. Clinical data

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

    Sex, vaccination status, level of education, occupation, smoking and alcohol behavior, other addictive behavior, competitive sports

  3. Physical assessment

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

    weight and height will be combined to report BMI in kg/m^2

  4. Heart rate

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

    beats per minute

  5. Blood pressure

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

    in mmHg

  6. Questionnaire data

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

    Following questionnaires are rated on a scale: MBSQ, Chalder Fatigue Scale, PedsQL Fatigue, Bell Score, DSQ-PEM, SF-36, PedsQL, EQ5D, PHQ4, Compass31

  7. YSR questionnaire

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

    Open questions and questions to be rated on a scale

  8. Imaging

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

    OCT-A: Imaging of ocular fundus

  9. Full blood count

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

    CRP, Ferritin, Creatinin, GPT and Immunglobuline

  10. Deformability Cytometer

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

    Cell-deformation

  11. Virology

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

    EBV, CMV, HSV1, HSV2 and Sars CoV2 antibodies

  12. Immunology

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

    ANA, Cystatin C, dsDNA Ak

  13. Endocrinology

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

    TPO antibodies

  14. B-cell phenotyping

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

    Analysis of surface antigens using cytometry by time of flights (CyTOF)

  15. Pain threshold

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

    Measuring pressure tolerancy in Newton by means of an algometer at the iliotibial tract, phalanx distalis III, trapezius muscle in triplicates

  16. Orthostasic Tolerance

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

    blood pressure and heart rate are measured during the 10-minute standing test to determine orthostasic tolerance

  17. Grip strength

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

    Hand dynamometer test to assess grip strength in Newton

  18. Smell test

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

    Recognition of different substances

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Dr. med. Uta Behrends

CONTACT

[email protected]

+49 89 3068 2793

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Charite University, Berlin, Germany
  • Max-Planck Institut
  • University Hospital Erlangen

Registry information

Official study title

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

Acronym: HelP

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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