- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06954922
The Effect of Memory-Based Exercise and Planned Training Applied to Epilepsy Patients on Quality of Life
Epilepsy; It is a chronic, neurological disease that can occur regardless of social class, race and age. Every year, approximately 5 million people worldwide are diagnosed with epilepsy and 50 million people are affected by this disease, constituting a significant part of the disease burden in the world. When we look at the rate of patients in the population who actively experience symptoms of the disease and need treatment, this rate is approximately 4 to 10 people per 1000 people. According to estimates, 700,000 people in Turkey are actively diagnosed with epilepsy. It is accepted that this disease occurs as a result of sudden, abnormal discharge of neurons in some parts of the central nervous system, and the disease generally progresses with recurrent changes in consciousness. The symptoms accompanying epilepsy are perceived negatively by patients and significantly affect their lives. Epilepsy treatment; It consists of several options such as medical drugs, ketogenic diet and surgical intervention. The ultimate goal of treatment is to achieve seizure control, reduce the frequency of seizures, minimize drug side effects that may occur due to long-term treatment, and improve the patient's quality of life. Along with pharmacological treatment, non-pharmacological treatment is also a valuable approach in the treatment of epilepsy. One of the non-pharmacological approaches is rehabilitation interventions with mind and memory exercises. Epilepsy is a disease that requires a complex psychological adaptation for the patient and affects the whole family. In this disease, it is very important for the patient to comply with the treatment requirements, to have self-control over his/her behavior, as well as to cope with the difficulties of living with epilepsy. Increasing the quality of life and preventing possible behavioral problems is possible by keeping mental functions at an optimal level on the one hand, and providing psychological counseling to the patient and his family on the other. Nowadays, epileptic seizures are often more easily controlled with developing pharmacological treatment options. Therefore, the fight against epilepsy should be expanded to include other educational, mental, psychotherapeutic and behavioral interventions besides drug therapy. In a study conducted by the National Center for Health and Care Research (NIHR), electrical activity scans in the brain of 25 epilepsy patients were examined. Some images in different categories were presented to epilepsy patients for a certain period of time. Later, when asked to remember the images shown in the previous step, it was noted that slow waves occurred in the brain during sleep. As a result of the research, it was revealed that the effect of epileptic spikes on brain activity decreased with the emergence of slow waves. This study has demonstrated for the first time a potential protective mechanism used by the brain to counteract epileptic activity. Patients diagnosed with epilepsy who are admitted to the neurology outpatient clinic or admitted to the neurology clinic will be introduced and informed about the study. Patients who want to participate in the study and meet the inclusion criteria will be determined. After patient consent is obtained, groups will be determined according to the randomization list.
The patient introduction form and the Quality of Life in Epilepsy Scale will be administered to the patients in both groups by the researcher using the face-to-face interview technique (pre-test). Patients in the experimental group will be informed about memory-based exercise and planned training.
Patients in the control group will only be informed about the planned training to be given.
The experimental group will be given memory-based exercises that will last approximately 15-20 minutes every day for 2 months. Four sessions of epilepsy training will be given, one session per week.
The control group will receive 4 sessions of epilepsy training, one session per week.
At the end of two months, the Quality of Life in Epilepsy Scale (posttest) will be applied to both groups.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being literate,
- Being over the age of 18,
- Having sufficient communication skills to answer oral and written questions and follow instructions,
- Being at a cognitive level to be able to use a mobile phone and perform the memory exercise.
- Not having severe vision problems,
- Having been diagnosed with epilepsy for at least 6 months
Exclusion Criteria:
- Being under 18 years of age
- Residing outside Bilecik Province
- Having psychiatric diagnoses such as Bipolar Disorder and Schizophrenia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: training group
|
This group will be given 4 sessions of epilepsy training, one session per week.
|
|
Experimental: memory-based exercise and training group
|
The experimental group will be given memory-based exercises that will last approximately 15-20 minutes every day for 2 months.
Four sessions of epilepsy training will be given, one session per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Introduction Form
Time Frame: 2 month
|
It was prepared by the researcher by examining the literature.
It consists of 26 questions, including questions such as age, gender, marital status, educational status, family type, social security, income status, epilepsy diagnosis period, frequency of seizures, presence of another disease, constantly used medication.
|
2 month
|
|
Quality of Life Scale in Epilepsy
Time Frame: 2 month
|
QOLIE-31 was developed by Vickrey et al. in 1993.
Mollaoğlu and his colleagues were the researchers who conducted the validity and reliability studies of this scale in Turkey in 2015.
QOLIE-31; It consists of a total of 31 questions and 7 subcomponents: 5 on the seizure-related concerns sub-dimension, 3 on the effects of medications sub-dimension, 4 on the energy/fatigue sub-dimension, 5 on the emotional well-being sub-dimension, 6 on the cognitive function sub-dimension, 5 on the social function sub-dimension, 2 on the total quality of life sub-dimension and an additional question assessing the total health status.
Scale scoring ranges from 0-100 points.
A high score indicates a high quality of life.
The total Cronbach's Alpha value in the original scale was determined to be 0.91.
In this study, the total Cronbach Alpha value of the scale was found to be 0.90.
|
2 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATAÜNİ-SBE-AS-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
NaviFUS CorporationTaipei Veterans General Hospital, TaiwanCompletedDrug Resistant Epilepsy | Epilepsy, Drug Resistant | Intractable Epilepsy | Refractory Epilepsy | Drug Refractory Epilepsy | Epilepsy, Drug Refractory | Epilepsy, Intractable | Medication Resistant EpilepsyTaiwan
-
Great Ormond Street Hospital for Children NHS Foundation...Active, not recruitingEpilepsies, Partial | Intractable Epilepsy | Focal Epilepsy | Refractory Epilepsy | Epilepsy Intractable | Epilepsy in Children | Epilepsy, FocalUnited Kingdom
-
University of British ColumbiaTerminatedJuvenile Myoclonic Epilepsy | Childhood Absence Epilepsy | Juvenile Absence EpilepsyCanada
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Oslo University HospitalCompletedEpilepsy | Generalized Epilepsy | Focal EpilepsyNorway
-
UCB Pharma SACompletedEpilepsy, Tonic-clonicPoland, Sweden, Hungary, Czechia
-
UCB PharmaCompletedEpilepsy, Tonic-clonic
-
Institute of Child HealthGreat Ormond Street Hospital for Children NHS Foundation TrustNot yet recruitingEpilepsy Intractable | Epilepsy in Children
-
University Hospital, LilleCompletedFocal Epilepsy | Epilepsy IntractableFrance
-
Massachusetts General HospitalBoston University; National Institute of Neurological Disorders and Stroke...CompletedEpilepsy | Epilepsy; Seizure | Rolandic Epilepsy | Rolandic Epilepsy, Benign | Centrotemporal Epilepsy | Centrotemporal; EEG Spikes, Epilepsy of ChildhoodUnited States
Clinical Trials on memory-based exercise and training intervention
-
Icahn School of Medicine at Mount SinaiCompletedDepression | Generalized Anxiety Disorder | Bipolar Disorder | Major Depressive Disorder | Social Phobia | Post-traumatic Stress DisorderUnited States
-
VA Office of Research and DevelopmentUniversity of MarylandCompleted
-
Umeå UniversityKarlstad UniversityRecruitingParkinson Disease | Cognitive ImpairmentSweden
-
Lancaster UniversityCompletedSuicidal Ideation | Mental Health DisorderUnited Kingdom
-
University of Electronic Science and Technology...RecruitingAutism Spectrum Disorder High-FunctioningChina
-
Kessler FoundationCompleted
-
St. Jude Children's Research HospitalAmerican Cancer Society, Inc.CompletedAcute Lymphoblastic Leukemia | Brain TumorUnited States
-
University of IsfahanCompletedAutism Spectrum Disorders
-
The University of Texas at DallasNational Institutes of Health (NIH)CompletedHearing ImpairedUnited States
-
Posit Science CorporationUniversity of San FranciscoUnknown