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The Effect of Cognitive Rehabilitation on Epileptic Pateints Under Treatment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06643559
Enrollment
368
Registered
2024-10-16
Start date
2022-06-01
Completion date
2023-08-01
Last updated
2024-10-16

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

Conditions

Cognitive Dysfunction, Epilepsy

Keywords

cognitive rehabillitation, antiseizure medication, MoCA, P300, N200

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.

Interventions

OTHERcognitive rehabilitation

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.

Sponsors

Gulhane Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Before monotherapy, newly diagnosed epileptic patients evaluted by MoCA and P300. The patients began their treatments, and from the next day, computer-based cognitive rehabilitation was randomly assigned to some patients in each drug group, four times a week. For each drug, patients were randomly divided into those who did not receive (A) and those who received (B) cognitive rehabilitation.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
MoCA2 monthsThe 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 Potentials2 monthsThe 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))

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026