Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05860998
Other study ID # 2023-00366
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 26, 2023
Est. completion date July 30, 2023

Study information

Verified date May 2023
Source University of Zurich
Contact Carlos Alós-Ferrer, PhD
Phone 798667160
Email carlos.alos-ferrer@econ.uzh.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators propose a fast and inexpensive procedure to determine the prevalence of the Toxoplasmosis infection (Toxoplasma Gondii) in the general population, using response times in a cognitive task instead of costly medical tests. Therefore, the investigators aim to measure the prevalence of Toxoplasmosis and its socio-economic consequences in the general population.


Description:

An estimated 2 billion humans worldwide are affected by the protozoan Toxoplasma gondii. The resulting Toxoplasmosis is considered one of the most important but most neglected parasitic infections. Toxoplasmosis has been linked to behavioral alterations in humans. While rarely resulting in an acute pathology, latent infections have been associated with non-clinical outcomes such as car accidents, impulsiveness, and suicides through the pathology's influence on personality and risk-taking behaviors. Given the economic and social impact of these consequences, it is important to have reliable estimates of Toxoplasmosis prevalence. However, current methods involve costly, time-expensive medical tests, which are not always available, especially in developing countries. Therefore, simpler, inexpensive, and easily-scalable diagnostic methods would be highly valuable. For this reason, both the CDC and the WHO consider it a priority to improve diagnostic testing of Toxoplasmosis. This includes obtaining reliable and easily-implementable estimates at the population level, which is essential to gauge the magnitude of the problem and to inform and design health policy aimed at reducing the number of infections in the population. Therefore, the investigators aim to determine the frequency of latent Toxoplasmosis infections in the general population in a simple, quick, and inexpensive way. The key idea of simplifying the diagnosis of this infection is that Toxoplasmosis induces specific behavioral and physiological changes. It alters the levels of neurotransmitters such as dopamine and causes a delay in muscle response time. In particular, people with RhD-negative blood type become slower when afflicted by Toxoplasmosis, while the RhD-positive sub-population does not experience a change in response times. This relation is important because, while the distribution of blood types can be determined in an inexpensive way and is already commonly known at the aggregate level (RhD-negative are 15% in Caucasians, 8% in Africans, and 1% in Asians), the actual prevalence of the Toxoplasmosis infection is underinvestigated, and the respective tests are costly and not easily deployable in large numbers (especially in developing countries). The investigators aim to leverage on the differential effects of Toxoplasmosis on response times across blood types to estimate its latent diffusion. Response times (RT) are known to be log-normally distributed [22]. This is crucial because mixtures of log-normally distributed variables are identifiable through standard statistical methods as e.g. finite mixture models [23]. The distribution of RTs in the population is a mixture of two different types, afflicted vs. non-afflicted, and the first group should show a systematic delay in RTs compared to the latter group. A finite mixture model can then be applied to a sample of RhD-negative individuals to estimate the characteristics of the two distributions and hence quantify both the magnitude of the delay in response times as well as the size of the afflicted group. The investigators already obtained data showing that the proposed method is able to capture interesting and economically-relevant individual characteristics between those who are imputed to be afflicted by this parasite compared to those who do not. This first investigation also passed some preliminary validation. For example, those estimated to be afflicted by Toxoplasmosis are also those who are more likely to have a cat, which is the main vector of contagion for this parasite. In this study the investigators propose a systematic validation of the proposed method. In particular, the investigators aim to compare it agrees with a standard medical test for Toxoplasmosis infection, e.g., compare it to the presence of Toxoplasma gondii IgG Antibodies. The latter medical test requires a blood sample.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date July 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Ability and willingness to participate in the study. - Declaration of consent. - Having RhD-Negative blood. This is because only RhD-negative blood type become slower when afflicted by Toxoplasmosis. Hence, the proposed analysis can only be performed on RhD-Negative people. - Good English language skills (at least C1, to ensure understanding of all instructions and the declaration of consent). Exclusion Criteria: - Inability to give the declaration of consent. - Any neurological disorders - Reduced general health / chronic diseases (e.g. autoimmune disease, severe cardiovascular diseases, insulin-dependent diabetes, severe depression); chronic pain disorders

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Presence of Toxoplasma gondii IgG Antibodies
Testing for the presence of Toxoplasma gondii IgG Antibodies in participants blood.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of Toxoplasma gondii IgG Antibodies Presence of Toxoplasma gondii IgG Antibodies 6 months
Primary Classified as afflicted by Toxoplasma gondii using response times Classification based on a reaction-time task of whether the participant is considered as afflicted by Toxoplasma gondii. 6 months
Secondary Big 5 personality trait Score in the Big 5 personality trait scale from Gosling et al. (2013). It is a 10-items scale subdivided in 5 traits (2 items for each trait): Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness to Experiences. Each item is evaluated using a 7-points Likert scale with the following labels "Disagree Moderately", "Disagree a little", "Neither agree not disagree", "Agree a little", "Agree moderately", "Agree strongly". For each trait one of the two items is reversely scored. For each of the 5 traits the score of the two items is added, hence it can go from 2 to 14. Higher scores on each of the scales correspond higher closeness to that personality trait, e.g., more agreeable. 6 months
Secondary Sensation Seeking scale Score in the Sensation Seeking scale (Cook et al., 2015). This scale consists of 10 binary choices where participants are asked to choose which option best describes their likes or the way they feel. One of the two options is associated with a higher Sensation Seeking score. Items 2, 3, 5, 6, and 8 are reversely scored. The answers from the single items are added to obtain the total score, which can go from 0 to 10. Higher scores indicate more sensation seeking. 6 months
Secondary Cognitive Reflection Test Score in the Cognitive Reflection Test from Toplak, West, and Stanovich (2014). In this 7-item scale each item asks for the answer to a mathematical or logical problem in an open-entry format or as multiple-choice question. The score for this scale is the sum of the correct answer to the 7 items, hence it goes from 0 to 7. Higher scores indicate higher cognitive reflections. 6 months
Secondary Risk aversion Measure of risk aversion (number from 1 to 10, Falk et al., 2018). A single question asking the participants' attitude toward risk. 1 means "not willing to take risks" and 10 means "very willing to take risks". Higher values mean more risk tolerance. 6 months
Secondary Time preference Measure of time preference (number from 1 to 10, Falk et al., 2018). A single question asking the participants' patience. 1 means "not willing to give up something today" and 10 means "very willing to give up something today". Higher values mean more patience. 6 months
Secondary Self-control Score in the self-control scale from Tangney, Boone, and Baumeister (2018). It is a 13-item scale evaluated using a 5-point Likert scale with two labels at the extreme of the scale 1="Not at all" and 5="Very much". Items 2/5, 7, 9/11 are reversely scored. The score is obtained by adding the score of the single items. Higher values indicate more self control. 6 months
Secondary Field of study Which major the participant studied. 6 months
Secondary Accidents Number of accidents (work related or traffic accidents) the participant experienced. 6 months
Secondary Owning Pets Which pets the participant owns or owned. 6 months
Secondary Income The yearly income (in Swiss Francs). 6 months
Secondary Alcohol consumption Average units of alcohol consumed in a week. 6 months
See also
  Status Clinical Trial Phase
Completed NCT03258762 - Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects Phase 1
Completed NCT01479361 - Antiretroviral Drug Interaction Study in Volunteers With HIV Phase 1
Not yet recruiting NCT05783778 - Evaluation of the Role of Latent Toxoplasmosis in Female Patients With Active Acne Vulgaris N/A
Not yet recruiting NCT04825600 - Diagnosis of Toxoplasma Gondii Infection by Exploration of Cellular Immunity (TOXCELL) N/A
Completed NCT03993093 - Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre
Recruiting NCT00004317 - Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis Phase 4
Withdrawn NCT03932656 - Latent Toxoplasmosis in Females With Borderline Personality Disorder
Not yet recruiting NCT05963295 - Toxoplasma Gondii Infection in Both Children and Adult Patients With Hematological Malignancies N/A
Not yet recruiting NCT06305468 - Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis
Completed NCT02011750 - Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia Phase 4