Clinical trial NCT06643559: The Effect of Cognitive Rehabilitation on Epileptic Pateints Under Treatment
Official title: Investigating The Effect Of Cognitive Rehabilitation On Cognitive Impairment Associated With Antiseizure Medications In Patients With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Dysfunction
Epilepsy
Keywords: cognitive rehabillitation
antiseizure medication
MoCA
P300, N200
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-16
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: MoCA
timeFrame: 2 months
measure: Cognitive Event Related Potentials
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Reseach Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.