EpilepsyNCT06954922
The Effect of Memory-Based Exercise and Planned Training Applied to Epilepsy Patients on Quality of Life
A study testing memory-based exercise and training intervention and educational initiative about epilepsy in people with Epilepsy and Memory Consolidation, run by Ataturk University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Memory Consolidation, Education of Patients
- What is being tested?
- memory-based exercise and training intervention and educational initiative about epilepsy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being under 18 years of age
- Residing outside Bilecik Province
- Having psychiatric diagnoses such as Bipolar Disorder and Schizophrenia
About this study
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.
Read more
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.
- Being tested
- memory-based exercise and training intervention, educational initiative about epilepsy
- Keywords
- quality of life, epilepsy, education of patiens, memory
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memory-based exercise and training interventionBehavioural
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.
educational initiative about epilepsyBehavioural
This group will be given 4 sessions of epilepsy training, one session per week.
| Study group | Role | What they receive |
|---|---|---|
| memory-based exercise and training group | Experimental | Not described Receives: Behavioral: memory-based exercise and training intervention |
| training group | Experimental | Not described Receives: Behavioral: educational initiative about epilepsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Introduction Form
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.
Measured: 2 month
Quality of Life Scale in Epilepsy
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.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study startMay 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMET ŞİMŞEK, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954922
- Sponsor's protocol ID
- ATAÜNİ-SBE-AS-02
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Memory-Based Exercise and Planned Training Applied to Epilepsy Patients on Quality of Life
- ClinicalTrials.gov ID
- NCT06954922
- Acronym / sponsor ID
- ATAÜNİ-SBE-AS-02
- Keywords
- quality of life, epilepsy, education of patiens, memory
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| memory-based exercise and training group | Experimental | Behavioral: memory-based exercise and training intervention |
| training group | Experimental | Behavioral: educational initiative about epilepsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- Being under 18 years of age
- Residing outside Bilecik Province
- Having psychiatric diagnoses such as Bipolar Disorder and Schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| memory-based exercise and training interventionThe 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. | Behavioural | memory-based exercise and training group |
| educational initiative about epilepsyThis group will be given 4 sessions of epilepsy training, one session per week. | Behavioural | training group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing memory-based exercise and training intervention and educational initiative about epilepsy in people with Epilepsy and Memory Consolidation, run by Ataturk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Introduction Form (time frame: 2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.