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Looking for signs of inflammation in the brain of Chronic Fatigue Syndrome Patients

Visualising Neuroinflammation in Chronic Fatigue Syndrome Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27481
Enrollment
20
Registered
2016-01-13
Start date
2016-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue syndrome Chronisch vermoeidheidssyndroom

Interventions

[11C]PK11195 (a ligand for the TSPO protein, upregulated in activated microglia cells) is injected in both patients, and healthy age- and sexe-matched controls. Binding of this tracer will be visualis

Sponsors

University Medical Center Groningen 9713 GZ Groningen, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Control subjects: - Female, between 18 and 60 years old; - Healthy age- and sexe-matched controls, i.e. live in the same neighbourhood as the Chronic Fatigue Syndrome patient Chronic Fatigue Syndrome (CFS) patients: -Diagnosis according to the Dutch guideline on QFS [RIVM, Q-koortsvermoeidheidssyndroom]; - Female, between 18 and 60 years old; - Score of ¡Ý40 on the subscale fatigue severity of the CIS (Checklist Individual Strength); - Marked functional impairment assessed with the Sickness Impact Profile (SIP-8) and operationalised as a total score of ¡Ý700.

Exclusion criteria

Exclusion criteria: All subjects: - Women who are pregnant; - Women who intend to get pregnant during the study; - Use or having used psychotropic medication in the past six months; - Alcohol or substance abuse in the past 3 months; - Evident somatic/psychiatric co-morbidity; - Presence of materials in the body that can be magnetized and cannot be removed; - Participation in a scientific research study during the past year involving radiation. - Use or having used Doxycyclin in the past 6 months; CFS patients, additional -History of Q fever; -Vaccinated for Q fever. Healthy volunteers, additional -History of Q fever; -Vaccinated for Q fever

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to evaluate whether there is an increased binding potential of the TSPO ligand [11C]PK11195, which is a marker for microglia activation in neuroinflammation, using PET in patients with chronic fatigue syndrome compared to Q-fever fatigue syndrome and healthy age- and sexe-matched controls.

Secondary

MeasureTime frame
- To correlate the binding potential of [11C]PK11195 to MRI measurements in the same patients (for example grey matter reduction). - To correlate binding potential of [11C]PK11195 to fatigue severity using the CIS fatigue questionnaire. - To correlate binding potential of [11C]PK11195 expression to peripheral cytokine concentrations.

Contacts

Public ContactRuud Raijmakers

Department of Internal Medicine, route 463 Radboudumc

Ruud.Raijmakers@radboudumc.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)