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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03450356
Other study ID # 2017-01193; me15Sollberger
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2018
Est. completion date March 31, 2020

Study information

Verified date August 2020
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Goal of the current project is the development of a German-language test battery for a realistic investigation of core areas of social issues Cognition (emotion, perspective taking). This test battery should be used in the investigation of patients with neuropsychological disorders. Investigators plan to establish a German-version of the TASIT that is more sensitive and shorter in administration than the original TASIT.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years and older
Eligibility Inclusion Criteria:

- from the age of 35,

- at least 7 years of education

- understand German or Swiss German

- Subjective statement of good health

- Signed consent

Exclusion Criteria:

- Montreal Cognitive Assessment (MoCA) value below the fifth percentile of subjectively cognitive healthy persons

- signs of depressive mood (Geriatric Depression Scale (GDS) score = 5 points or Beck Depression Inventory (BDI) = 10 points)

- Severe sensory deficits with potentially negative influence test results

- Severe motor deficits with potentially negative influence test results

- Systemic diseases or brain diseases with potentially negative Influence on test results

- St. n. Traumatic brain injury (with unconsciousness of at least 30 minutes)

- Severe pain with potentially negative influence on the test results

- Psychiatric problems like alcohol dependence syndrome or Schizophrenia according to Diagnostic and Statistical Manual (DSM)®-5

- Regular use of drugs with potentially negative Influence on the test results with the exception of taking Benzodiazepines at night

- general anesthesia less than 3 months ago

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland University Hospital Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy rate in emotion perception and perception of beliefs and intentions The proportion of top scorers for any question - i.e. the proportion of participants who reach the full score of a specific scene. This proportion will be estimated for each scene and intensity separately with 95% confidence interval. 60 minutes
Primary Accuracy rate in perception of beliefs The proportion of top scorers for any question - i.e. the proportion of participants who reach the full score of a specific scene. This proportion will be estimated for each scene and intensity separately with 95% confidence interval. 60 minutes
Primary Accuracy rate in perception of intentions The proportion of top scorers for any question - i.e. the proportion of participants who reach the full score of a specific scene. This proportion will be estimated for each scene and intensity separately with 95% confidence interval. 60 minutes
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