Intellectual Disability and Epilepsy in Adults: cognitive trajectories and targets for care and interventions

Intellectual Disability and Epilepsy in Adults: cognitive trajectories and targets for care and interventions - IDEA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55030

Enrollment

285

Registered

2021-02-01

Start date

2021-03-01

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

aging cognition

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Study 1: Having participated in the earlier study TRIANGLE Study 2: Be over the age of 18 and have a genetically confirmed diagnosis of one of following four syndromes; Fragile X Syndrome, Tuberous Sclerosis Complex, Angelman Syndrome, SCN1A mutations

Exclusion criteria

Exclusion criteria: Across both studies: No informed consent given by legal representative or the subject (if legally capacitated) Study 2: An additional genetic diagnosis

Design outcomes

Primary

Measure	Time frame
Study 1 will have two main outcomes: 1) The difference in adaptive functioning (as measured with the Vineland Adaptive Behavior Scale-II (VABS-II)) when the outcomes of the TRIANGLE study are compared to the outcomes of the current study. 2) The relationship between changes in adaptive functioning and serum levels of neurofilament light chains. Study 2 will have one main outcome: 1) The relationship between changes in adaptive functioning and serum levels of neurofilament light chains in the different genetic syndromes.	—

Measure

Time frame

Study 1 will have two main outcomes: 1) The difference in adaptive functioning (as measured with the Vineland Adaptive Behavior Scale-II (VABS-II)) when the outcomes of the TRIANGLE study are compared to the outcomes of the current study. 2) The relationship between changes in adaptive functioning and serum levels of neurofilament light chains. Study 2 will have one main outcome: 1) The relationship between changes in adaptive functioning and serum levels of neurofilament light chains in the different genetic syndromes.

—

Secondary

Measure	Time frame
Secondary study parameters include: The neuropsychological outcome measures: - Measure of cognitive problems such as memory and intelligence; - Severity of affective symptoms (including depressive and anxiety symptoms); and other behavioral symptoms	—

Countries

Netherlands

Outcome results