The Effect of Cognitive Rehabilitation on Epileptic Pateints Under Treatment

NCT ID: NCT06643559

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-08-01

Brief Summary

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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

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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.

Conditions

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Cognitive Dysfunction Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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patients with cognitive rehabilitation

Patient which have started antiseizure monotherapy plus have been included cognitive rehabilitation programme.

Group Type ACTIVE_COMPARATOR

cognitive rehabilitation

Intervention Type 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.

Patients Without Cognıtıve Rehabilitation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gulhane Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Omer Karadas

Prof.Dr.Omer Karadas

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gulhane Training and Reseach Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Baxendale S. Cognitive rehabilitation and prehabilitation in people with epilepsy. Epilepsy Behav. 2020 May;106:107027. doi: 10.1016/j.yebeh.2020.107027. Epub 2020 Mar 21.

Reference Type RESULT
PMID: 32208338 (View on PubMed)

Choi J, Twamley EW. Cognitive rehabilitation therapies for Alzheimer's disease: a review of methods to improve treatment engagement and self-efficacy. Neuropsychol Rev. 2013 Mar;23(1):48-62. doi: 10.1007/s11065-013-9227-4. Epub 2013 Feb 12.

Reference Type RESULT
PMID: 23400790 (View on PubMed)

Duncan CC, Barry RJ, Connolly JF, Fischer C, Michie PT, Naatanen R, Polich J, Reinvang I, Van Petten C. Event-related potentials in clinical research: guidelines for eliciting, recording, and quantifying mismatch negativity, P300, and N400. Clin Neurophysiol. 2009 Nov;120(11):1883-1908. doi: 10.1016/j.clinph.2009.07.045. Epub 2009 Sep 30.

Reference Type RESULT
PMID: 19796989 (View on PubMed)

Farina E, Raglio A, Giovagnoli AR. Cognitive rehabilitation in epilepsy: An evidence-based review. Epilepsy Res. 2015 Jan;109:210-8. doi: 10.1016/j.eplepsyres.2014.10.017. Epub 2014 Nov 6.

Reference Type RESULT
PMID: 25524861 (View on PubMed)

Ismail Z, Aguera-Ortiz L, Brodaty H, Cieslak A, Cummings J, Fischer CE, Gauthier S, Geda YE, Herrmann N, Kanji J, Lanctot KL, Miller DS, Mortby ME, Onyike CU, Rosenberg PB, Smith EE, Smith GS, Sultzer DL, Lyketsos C; NPS Professional Interest Area of the International Society of to Advance Alzheimer's Research and Treatment (NPS-PIA of ISTAART). The Mild Behavioral Impairment Checklist (MBI-C): A Rating Scale for Neuropsychiatric Symptoms in Pre-Dementia Populations. J Alzheimers Dis. 2017;56(3):929-938. doi: 10.3233/JAD-160979.

Reference Type RESULT
PMID: 28059789 (View on PubMed)

Ismail Z, Rajji TK, Shulman KI. Brief cognitive screening instruments: an update. Int J Geriatr Psychiatry. 2010 Feb;25(2):111-20. doi: 10.1002/gps.2306.

Reference Type RESULT
PMID: 19582756 (View on PubMed)

Engelberts NH, Klein M, Ader HJ, Heimans JJ, Trenite DG, van der Ploeg HM. The effectiveness of cognitive rehabilitation for attention deficits in focal seizures: a randomized controlled study. Epilepsia. 2002 Jun;43(6):587-95. doi: 10.1046/j.1528-1157.2002.29401.x.

Reference Type RESULT
PMID: 12060017 (View on PubMed)

Jones MK. Imagery as a mnemonic aid after left temporal lobectomy: contrast between material-specific and generalized memory disorders. Neuropsychologia. 1974 Jan;12(1):21-30. doi: 10.1016/0028-3932(74)90023-2. No abstract available.

Reference Type RESULT
PMID: 4821186 (View on PubMed)

Koorenhof L, Baxendale S, Smith N, Thompson P. Memory rehabilitation and brain training for surgical temporal lobe epilepsy patients: a preliminary report. Seizure. 2012 Apr;21(3):178-82. doi: 10.1016/j.seizure.2011.12.001. Epub 2011 Dec 23.

Reference Type RESULT
PMID: 22197200 (View on PubMed)

Loring DW, Meador KJ. Epilepsy: maximizing cognitive outcomes in epilepsy. Nat Rev Neurol. 2012 Aug;8(8):416-7. doi: 10.1038/nrneurol.2012.143. Epub 2012 Jul 10. No abstract available.

Reference Type RESULT
PMID: 22777245 (View on PubMed)

Ortinski P, Meador KJ. Cognitive side effects of antiepileptic drugs. Epilepsy Behav. 2004 Feb;5 Suppl 1:S60-5. doi: 10.1016/j.yebeh.2003.11.008.

Reference Type RESULT
PMID: 14725848 (View on PubMed)

Ponds RW, Hendriks M. Cognitive rehabilitation of memory problems in patients with epilepsy. Seizure. 2006 Jun;15(4):267-73. doi: 10.1016/j.seizure.2006.02.011. Epub 2006 Mar 23.

Reference Type RESULT
PMID: 16563809 (View on PubMed)

Quon RJ, Mazanec MT, Schmidt SS, Andrew AS, Roth RM, MacKenzie TA, Sajatovic M, Spruill T, Jobst BC. Antiepileptic drug effects on subjective and objective cognition. Epilepsy Behav. 2020 Mar;104(Pt A):106906. doi: 10.1016/j.yebeh.2020.106906. Epub 2020 Jan 29.

Reference Type RESULT
PMID: 32006792 (View on PubMed)

Rosca EC, Simu M. Montreal cognitive assessment for evaluating cognitive impairment in multiple sclerosis: a systematic review. Acta Neurol Belg. 2020 Dec;120(6):1307-1321. doi: 10.1007/s13760-020-01509-w. Epub 2020 Sep 29.

Reference Type RESULT
PMID: 32996098 (View on PubMed)

Shafiyev J, Karadas O. The assessment of the impact of antiepileptic drugs on cognitive functions via N-200/P-300 potentials and neuropsychological measures. Neurol Sci. 2024 Oct;45(10):5011-5021. doi: 10.1007/s10072-024-07606-5. Epub 2024 May 25.

Reference Type RESULT
PMID: 38795272 (View on PubMed)

Witt JA, Elger CE, Helmstaedter C. Adverse cognitive effects of antiepileptic pharmacotherapy: Each additional drug matters. Eur Neuropsychopharmacol. 2015 Nov;25(11):1954-9. doi: 10.1016/j.euroneuro.2015.07.027. Epub 2015 Aug 6.

Reference Type RESULT
PMID: 26296280 (View on PubMed)

Witt JA, Helmstaedter C. Cognition in the early stages of adult epilepsy. Seizure. 2015 Mar;26:65-8. doi: 10.1016/j.seizure.2015.01.018. Epub 2015 Feb 7.

Reference Type RESULT
PMID: 25799904 (View on PubMed)

Other Identifiers

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CR ethics commitee 2022/84

Identifier Type: -

Identifier Source: org_study_id

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