The Effect of Cognitive Rehabilitation on Epileptic Pateints Under Treatment

Not Applicable

Completed

• Conditions: Cognitive Dysfunction; Epilepsy

• Registration Number: NCT06643559
• Lead Sponsor: Gulhane Training and Research Hospital

Brief Summary

It is clear that studies on cognitive rehabilitation in epilepsy patients mostly focus on patients undergoing epilepsy surgery and are largely classified according to the type of epilepsy. The main purpose of this study is to determine whether cognitive impairments associated with antiepileptic drugs develop in epilepsy patients using neuropsychological tests and event-related potentials, and if such an impairment is present, to investigate whether cognitive rehabilitation is beneficial.

Detailed Description

Patients who were planned to start monotherapy were first included in the study by performing a face-to-face MoCA test. After the MoCA test, experienced neurologists measured event-related potentials, including P300 and N200 potentials and N2P3 amplitudes, in the electrophysiology laboratory. Patients for each drug were randomly assigned to the no cognitive rehabilitation group (A) or the cognitive rehabilitation group (B). At the end of the second month, MoCA test and event-related potential measurements were performed again in both groups, and the results were analyzed statistically.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-13
• Last Update Submitted: 2024-10-13
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

• Newly diagnosis of epilepsy, -
• Before monotherapy had started

Exclusion Criteria

• diagnosis of psychogenic non-epileptic seizures,
• epileptic patients currently receiving antiepileptic drugs,
• epileptic patients exhibiting cognitive dysfunction
• epileptic patientswith dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
MoCA	2 months	The Montreal Cognitive Assessment (MoCA) is a 30-point screening test that takes approximately 10 minutes to administer. It assesses executive functioning, visuospatial abilities, memory, attention, working memory, language, and orientation. It has high sensitivity and specificity. the maximum score is 30. Higher scores mean a better outcome.
Cognitive Event Related Potentials	2 months	The standardized recording protocol was utilized to acquire reliable and consistent Event-Related Potentials (ERP) data for a comprehensive evaluation of the brain's response to auditory stimuli. In the analysis of potentials, the amplitude between the N200 and P300 was measured from the N200 peak to the P300 peak. The latencies of the N200 and P300 potentials were also determined by identifying the midpoint of each potential (latencies in miliseconds (ms) and amplitudes in microvolt (uV))

Trial Locations

Locations (1)

Gulhane Training and Reseach Hospital; 🇹🇷 Ankara, Turkey