The Effect of Cognitive Rehabilitation on Epileptic Pateints Under Treatment

NCT06643559 | Completed DMC

• 1 other identifier: CR ethics commitee 2022/84
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction; Epilepsy

Keywords

cognitive rehabillitation; antiseizure medication; MoCA; P300, N200

Outcome Measures

Primary Outcomes (2)

• MoCA

  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

  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

Study Arms (2)

patients with cognitive rehabilitation

ACTIVE COMPARATOR

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

Other: cognitive rehabilitation

Patients Without Cognıtıve Rehabilitation

NO INTERVENTION

Interventions

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.

patients with cognitive rehabilitation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Newly diagnosis of epilepsy, -
• Before monotherapy had started

You may not qualify if:

• diagnosis of psychogenic non-epileptic seizures,
• epileptic patients currently receiving antiepileptic drugs,
• epileptic patients exhibiting cognitive dysfunction
• epileptic patientswith dementia

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Gulhane Training and Reseach Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (17)

• 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.

  PMID: 32208338 RESULT

• 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.

  PMID: 23400790 RESULT

• 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.

  PMID: 19796989 RESULT

• 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.

  PMID: 25524861 RESULT

• 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.

  PMID: 28059789 RESULT

• 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.

  PMID: 19582756 RESULT

• 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.

  PMID: 12060017 RESULT

• 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.

  PMID: 4821186 RESULT

• 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.

  PMID: 22197200 RESULT

• 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.

  PMID: 22777245 RESULT

• 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.

  PMID: 14725848 RESULT

• 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.

  PMID: 16563809 RESULT

• 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.

  PMID: 32006792 RESULT

• 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.

  PMID: 32996098 RESULT

• 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.

  PMID: 38795272 RESULT

• 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.

  PMID: 26296280 RESULT

• 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.

  PMID: 25799904 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction; Epilepsy

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.Omer Karadas

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 16, 2024
• Study Start: June 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

TU (1)