The Effect of Cognitive Rehabilitation on Epileptic Pateints Under Treatment

October 13, 2024 updated by: Omer Karadas, Gulhane Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

368

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Gulhane Training and Reseach Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: patients with cognitive rehabilitation
Patient which have started antiseizure monotherapy plus have been included cognitive rehabilitation programme.
Other: cognitive 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.
No Intervention: Patients Without Cognıtıve Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months
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))
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulhane Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 13, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 13, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR ethics commitee 2022/84

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on cognitive rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe