Cognitive Intervention for Epilepsy

Overseen By Anthony Lioi, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kayela Arrotta

Disqualifiers: Non-epileptic seizures, Cognitive rehab, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cognitive interventions (exercises to improve thinking skills) can help people with epilepsy reduce cognitive lapses and boost brain health. Participants will join weekly virtual group sessions for 12 weeks, guided by a neuropsychologist, and then continue practicing independently for nine months. Researchers will compare the results of those who participate in these sessions with those who do not to determine if there's a noticeable improvement. This trial suits adults with epilepsy who experience cognitive difficulties and have internet access for online sessions. As an unphased trial, this study offers a unique opportunity for participants to contribute to groundbreaking research that could enhance cognitive health for those with epilepsy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on cognitive interventions, so it's likely you can continue your current treatment, but you should confirm with the study team.

What prior data suggests that this cognitive intervention is safe for individuals with epilepsy?

Research has shown that treatments focusing on thinking and behavior for epilepsy are generally safe. They are affordable, easy to use, and lack serious side effects. These treatments aim to improve thinking and memory through activities like online group sessions. Previous studies have found that similar approaches can help reduce stress and boost mental health without causing harm. Participants typically handle these sessions well. This strong safety record makes this type of treatment a promising option for those seeking to improve brain health and reduce memory problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike conventional epilepsy treatments that often focus on medication or surgery, the Cognitive Enhancement Intervention is distinctive because it explores a non-invasive approach through behavioral therapy. This treatment involves live, virtual group sessions designed to enhance cognitive function over 12 weeks, offering a potential new way to improve mental processing and quality of life for epilepsy patients. Researchers are excited about this trial as it could reveal innovative strategies to manage cognitive symptoms associated with epilepsy, providing a complementary option alongside traditional medical treatments.

What evidence suggests that this cognitive intervention is effective for epilepsy?

Research has shown that certain activities can help people with epilepsy enhance their thinking and memory. Some studies suggest that lifestyle changes, such as practicing mindfulness and exercising, can reduce stress, potentially leading to fewer seizures and improved brain health. These activities are noninvasive and typically lack serious side effects, making them a safe choice for many. Early results from similar activities have shown promise in reducing memory problems in people with epilepsy. In this trial, participants in the Cognitive Intervention group will attend weekly, live, virtual group sessions for 12 weeks, aiming to improve mental abilities through group sessions and personal practice. ^{1 2 3 4 5}

Who Is on the Research Team?

Kayela Arrotta, PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have never had surgery for epilepsy.

Potential patients will be identified if they have been, or are scheduled to be seen, either in-person or virtually for a clinical visit within the Cleveland Clinic Epilepsy Center

Fluent in English

Exclusion 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.

Currently pregnant or less than 6 weeks postpartum

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cognitive Intervention

Participants receive weekly, live, virtual group sessions led by a neuropsychologist for 12 weeks

12 weeks

12 visits (virtual)

Self-study

Participants practice what they learned during the intervention for 9 months

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Enhancement Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Cognitive Intervention Experimental Treatment 1 Intervention

Participants in this group will receive weekly, live, virtual group sessions for 12 weeks

Group II: Control Active Control 1 Intervention

Participants in this group will NOT receive the group sessions

Who Is Running the Clinical Trial?

Kayela Arrotta

Lead Sponsor

Trials

2

Recruited

230+

Published Research Related to This Trial

This study will evaluate a psychological-behavioral intervention designed to improve cognitive functioning and quality of life in adults with epilepsy, involving six individual and two group sessions led by a certified psychologist.

The trial aims to fill significant gaps in research regarding cognitive rehabilitation in epilepsy, particularly focusing on its effects on long-term memory and the role of epilepsy-specific factors in treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of cognition and psychosocial well-being - a better life with epilepsy (ReCaP-ABLE): a protocol for a randomized waitlist-controlled trial. Puteikis, K., Jakonienė, A., Jasionis, A., et al.[2023]

Both healthy controls and left temporal lobe epilepsy (LTLE) patients showed improvements in verbal memory performance after participating in a memory rehabilitation program that included memory support strategies.

LTLE patients reported significant improvements in their subjective memory ratings, particularly linked to mood enhancements, but pre-operative rehabilitation did not lead to better outcomes compared to post-operative interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory rehabilitation and brain training for surgical temporal lobe epilepsy patients: a preliminary report. Koorenhof, L., Baxendale, S., Smith, N., et al.[2014]

In a study of 316 adults with epilepsy, 46% reported substantial subjective cognitive impairment (SCI), which was significantly linked to restrictions in daily life (RDL) and reduced daily activities (DA).

SCI accounted for 23% of the variance in RDL and 24% in DA, indicating it is a major factor affecting everyday functioning, especially in patients with depressive symptoms who may experience even greater challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjective cognition is linked to everyday functioning in epilepsy. Hohmann, L., Berger, J., Kastell, SU., et al.[2023]

A minimal structured psycho-educational intervention for children and adolescents with epilepsy, involving a 4-hour session using Cognitive Behavioural Therapy techniques, significantly improved coherence, psychological distress, and sleep problems after three months.

The study involved 24 participants (12 in the intervention group and 12 in the control group), and the results suggest that this brief intervention can enhance self-management and reduce psychological issues related to epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a self-regulation based psycho-educational pilot intervention targeting children and adolescents with epilepsy in Greece. Rizou, I., De Gucht, V., Papavasiliou, A., et al.[2018]

The SPACE intervention, a novel psychoeducational program for children with epilepsy and attention difficulties, showed significant improvements in executive functioning and health-related quality of life (HRQOL) after three months, based on assessments from parents and teachers.

All 16 participants completed the intervention, and qualitative feedback was positive, suggesting that SPACE could be an effective first-line treatment for children with epilepsy at risk for ADHD, although further studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting Attention in Children with Epilepsy (SPACE): Pilot of a psychoeducational intervention. Svanström, K., Hallböök, T., Rezanova, J., et al.[2023]

The HOBSCOTCH program, a self-management intervention for adults with epilepsy, significantly improved quality of life and cognitive performance, particularly in attention, over an 8-week period compared to a waitlisted control group of 66 participants.

While the intervention showed benefits in quality of life and cognitive function, it did not result in significant changes in depression scores, indicating that while cognitive issues can be addressed, mood-related challenges may require different approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cognitive behavioral intervention (HOBSCOTCH) improves quality of life and attention in epilepsy. Caller, TA., Ferguson, RJ., Roth, RM., et al.[2022]

The study involved 52 young adults with epilepsy and mild cognitive impairment, who spent about 3 years in a residential unit aimed at improving their independence and seizure control.

At discharge, participants showed a decline in seizure frequency, and those who moved to supported housing experienced significant improvements in health-related quality of life and daily living activities, indicating that the residential program can have positive effects beyond just reducing seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A time-limited residential unit for young adults with epilepsy and mild cognitive impairment: results of a prospective pre-post-study. Endermann, M.[2015]

A 1-hour memory enhancement course for 39 individuals with epilepsy led to significant and sustained improvements in cognitive abilities and self-management skills, as assessed at multiple follow-up points.

While the course was well-received by participants, it did not result in improvements in quality of life or seizure severity, indicating that while cognitive support is beneficial, it may not directly affect other aspects of living with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a brief memory enhancement course on individuals with epilepsy. Bautista, RED., Smith, L., Smith, FL., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05283200

Creating a Healthy L.I.F.E: Lifestyle Interventions For ... The aim of this intervention is for participants to learn and develop skills to reduce stress which may, in turn, decrease seizure frequency and improve ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05954182/cognitive-enhancement-intervention-for-creating-a-healthy-life-lifestyle-interventions-for-epilepsy

Cognitive Enhancement Intervention for Creating a Healthy ... The goal of this clinical trial is to test if cognitive interventions in those with diagnosed epilepsy can help lessen cognitive lapses and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11450595/

Proceedings of the 2022 “Lifestyle Intervention for Epilepsy ... There is research to suggest that certain lifestyle changes, such as yoga, mindfulness, exercise, music therapy, and adjustments to diet, could help people ...

4. withpower.com withpower.com/trial/phase-epilepsy-6-2023-56070

Cognitive Intervention for Epilepsy This trial tests if online group sessions led by a brain health expert can help people with epilepsy improve their thinking and memory skills.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6094950/

Cognitive and behavioral interventions in epilepsy - PMC Cognitive and behavioral treatments for epilepsy offer several advantages, as they are relatively low cost, are noninvasive, lack serious side effects, and ...