NCT03450356

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

February 23, 2018

Last Update Submit

August 11, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • from the age of 35,
  • at least 7 years of education
  • understand German or Swiss German
  • Subjective statement of good health
  • Signed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Basel, 4044, Switzerland

Location

Study Officials

  • Marc Sollberger, PD Dr.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

January 2, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations