What side effects are associated with this type of intervention?

Common treatments for epilepsy include antiepileptic drugs such as gabapentin, lamotrigine, topiramate, tiagabine, and valproate. These medications are generally effective but can have side effects. Gabapentin may cause dizziness and fatigue; lamotrigine can lead to skin rashes and, rarely, severe hypersensitivity reactions; topiramate is associated with cognitive side effects like memory issues and confusion; tiagabine may cause dizziness and difficulty concentrating; and valproate can lead to weight gain, tremors, and hair loss. Cognitive and behavioral therapies, while not directly treating seizures, aim to improve cognitive function and quality of life without the pharmacological side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of epilepsy, including gabapentin, lamotrigine, topiramate, tiagabine, valproate, oxcarbazepine, levetiracetam, and zonisamide. These medications have been shown to be effective in managing seizures in various forms of epilepsy. Gabapentin and lamotrigine are particularly noted for their efficacy in partial seizures, while valproate is often used for generalized epilepsy. Cognitive interventions, such as those being studied in the Cognitive Interventions trial, aim to complement these pharmacological treatments by addressing cognitive lapses and improving overall brain health in epilepsy patients.

What other types of research exist?

Promising novel alternatives to cognitive interventions for epilepsy patients include seizure forecasting and EEG-triggered closed-loop seizure intervention systems. These technologies aim to predict and prevent seizures in real-time, offering a proactive approach to epilepsy management. Additionally, advancements in neurostimulation techniques, such as responsive neurostimulation (RNS) and transcranial magnetic stimulation (TMS), are being explored as potential treatments for refractory epilepsy.

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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-12 months for reporting.

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 more

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

Do I qualify?Apply below to find out

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.

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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

Media Library

Cognitive Enhancement Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05954182 — N/A

Epilepsy Research Study Groups: Control, Cognitive Intervention

Epilepsy Clinical Trial 2023: Cognitive Enhancement Intervention Highlights & Side Effects. Trial Name: NCT05954182 — N/A

Cognitive Enhancement Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05954182 — N/A

~106 spots leftby Jun 2026

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