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Completed

NCT Number: NCT06643559

The Effect of Cognitive Rehabilitation on Epileptic Pateints Under Treatment

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.

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Key information

Conditions

Cognitive Dysfunction Brain Diseases Central Nervous System Diseases Cognition Disorders Epilepsy Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane Training and Reseach Hospital

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive rehabilitation

Other

Cognitive rehabilitation started to one group at the beginning of the antiseizure medicine. Participants underwent computer-based cognitive rehabilitation for 3 sessions per week, with each session lasting an average of 60 minutes. Before the sessions, all participants were given detailed information about the programme and its use. The rehabilitation process was carried out in three areas of cognitive functions: memory, executive functions, and language skills.

Primary outcomes

  1. MoCA

    Time frame: 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.

  2. Cognitive Event Related Potentials

    Time frame: 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))

Sponsors and collaborators

Lead sponsor

Gulhane Training and Research Hospital

Other Gov

Registry information

Official study title

Investigating The Effect Of Cognitive Rehabilitation On Cognitive Impairment Associated With Antiseizure Medications In Patients With Epilepsy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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