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Behavioral Intervention
Cognitive Intervention for Epilepsy
N/A
Recruiting
Led By Kayela Arrotta, PhD
Research Sponsored by Kayela Arrotta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if online group sessions led by a brain health expert can help people with epilepsy improve their thinking and memory skills. Participants will join regular sessions for a few months and then practice on their own for several more months. The goal is to see if these mental exercises can enhance daily functioning and overall brain health.
Who is the study for?
Adults aged 18-60 with diagnosed epilepsy, fluent in English, and able to consent can join. They must have internet access for online sessions and no history of epilepsy surgery. Excluded are those with serious psychiatric conditions or intensive medical treatments, recent pregnancy/postpartum, significant sensory loss, prior cognitive rehab within 6 months, or pending epilepsy surgery.
What is being tested?
The trial tests if weekly virtual cognitive intervention sessions led by a neuropsychologist over 12 weeks plus continued practice for 9 months can improve brain health in people with epilepsy. Participants' progress is compared to others who don't receive the intervention.
What are the potential side effects?
Since this is a non-drug intervention focusing on cognitive exercises and education, traditional medication side effects are not expected. However, participants may experience fatigue or stress related to regular participation in the program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Everyday Functioning
Secondary study objectives
Change in Cognitive function
Change in Mood
Change in Quality of Life
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive InterventionExperimental Treatment1 Intervention
Participants in this group will receive weekly, live, virtual group sessions for 12 weeks
Group II: ControlActive Control1 Intervention
Participants in this group will NOT receive the group sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Intervention
2017
N/A
~1120
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for epilepsy include antiepileptic drugs (AEDs) such as carbamazepine, valproate, and lamotrigine. These medications work by stabilizing neuronal membranes and reducing excitability, either by enhancing inhibitory neurotransmission (e.g., increasing GABA activity) or by inhibiting excitatory neurotransmission (e.g., blocking sodium or calcium channels).
This is crucial for epilepsy patients as it helps to prevent the abnormal electrical activity in the brain that leads to seizures. Cognitive interventions, like those being studied in the trial, aim to improve brain health and cognitive function, which can be impaired in epilepsy patients due to both the condition and its treatment.
These interventions may complement AEDs by addressing cognitive deficits and enhancing overall quality of life.
Experimental and clinical studies on the putative therapeutic efficacy of cerebral irradiation (radiotherapy) in epilepsy.Transcranial magnetic stimulation and epilepsy.
Experimental and clinical studies on the putative therapeutic efficacy of cerebral irradiation (radiotherapy) in epilepsy.Transcranial magnetic stimulation and epilepsy.
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Who is running the clinical trial?
Kayela ArrottaLead Sponsor
1 Previous Clinical Trials
64 Total Patients Enrolled
1 Trials studying Epilepsy
64 Patients Enrolled for Epilepsy
Kayela Arrotta, PhDPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
64 Total Patients Enrolled
1 Trials studying Epilepsy
64 Patients Enrolled for Epilepsy
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving intense treatment for a serious illness that may affect my participation in the study.I am scheduled for epilepsy surgery within the next 6 months.I am between 18 and 60 years old and have been diagnosed with epilepsy.I have never had surgery for epilepsy.I have had seizures not caused by epilepsy.I need someone else to make medical decisions for me.I can understand and agree to the study on my own.I have participated in cognitive rehabilitation in the past 6 months.I am willing and able to participate in brain health activities.I can access the internet and join video calls.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Cognitive Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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