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The Cologne Executive Assessment (KEX): Validation of a screening tool for executive dysfunction in patients with Idiopathic Parkinson's Disease

The Cologne Executive Assessment (KEX): Validation of a screening tool for executive dysfunction in patients with Idiopathic Parkinson's Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00030791
Enrollment
250
Registered
2022-11-22
Start date
2022-12-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

G20

Interventions

Group 1: The target group consists of patients with IPS who present to the clinic as part of routine clinical practice or those who are hospitalized there if necessary for clinical reasons. Control su

Sponsors

Universitätsklinikum Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients: - Only patients with IPS from the Department of Neurology who present to the Department of Neurology as part of routine clinical care or those who are hospitalized there if necessary for clinical indication. - Male, female and diverse - 18-90 years - Unimpaired or sufficiently corrected (glasses, hearing aid, etc.) - Sufficient knowledge, adequate speech - No other clinically relevant neurological disease besides IPS. - No parkinsonism of non-idiopathic form. - No moderate or severe medical conditions that interfere with the ability to complete the survey. - No known substantial impairments. - Consented and signed Control subjects: - Individuals who do not have court-ordered supervision. - Male, female, diverse - 18-90 years of age - Unimpaired or sufficiently corrected (glasses, hearing aid, etc.) - Sufficient language skills - No neurological or psychiatric conditions or other moderate or severe conditions that interfere with ability to complete the survey. - No known impairments - Consented and signed

Exclusion criteria

Exclusion criteria: Patients: - Possible subjects dependent on the study investigators. - 90 years - Limited - Insufficient language skills, substantial language impairment. - Other clinically relevant neurological disease besides IPS. - Parkinsonism of non-idiopathic form. - Moderate or severe disease that interferes with ability to complete the survey. - Known substantial impairment. - Not consented, not signed. Control subjects: - Individuals who have court-ordered supervision; - Potential subjects dependent on the study investigators. - 90 years of age - Limited language skills - Neurological or psychiatric illness or other moderate or severe illness that interferes with ability to complete the survey. - Substantial impairment - Not consented, not signed

Design outcomes

Primary

MeasureTime frame
The aim of the study is to validate the KEX Cologne Executive Test with established neuropsychological procedures and to test its sensitivity and specificity using a clinical population with prominent executive disorders (Parkinson's patients). The collected data will be statistically analyzed using the statistical program IBM SPSS Statistics 27. Descriptive statistics (mean, standard deviation, etc.) are calculated to reflect the characteristics of the sample. The quality of the patients'/control subjects' data is determined using standard values (missing data 90%; floor and ceiling effects [standard < 16%]; skewness [standard -1 to +1]). In addition, item analysis (item difficulty, item homogeneity, and item discriminant power) is performed and the reliability of the subtests (Cronbach's alpha) is calculated. Statistical procedures used also include the t-test for independent samples for comparison between healthy controls and patients and correlation analyses (Spearman/Pearson correlation coefficients) between the subtests of the KEX and the corresponding already validated tests to determine convergent and divergent validity. Receiver operating characteristic (ROC) curves will also be used to determine cut-off values as well as sensitivity and specificity of the KEX. Another aim of the study, in addition to the evaluation of the KEX, is the validation of the cognitive test EVA (Executive Functions, Verbal Fluency, and Recall). The study aims to examine the reliability, validity, sensitivity, and specificity of the test in a clinical sample of patients with executive dysfunctions (patients with Parkinson’s disease).

Secondary

MeasureTime frame
Correlations with established test procedures

Countries

Germany

Contacts

Public ContactStefanie Jost

Universitätsklinikum Köln

Stefanie.Jost@uk-koeln.de+492214784011

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026