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 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.

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.

Is the Cognitive Intervention for Epilepsy safe for humans?

The studies on cognitive interventions for epilepsy, such as memory enhancement courses and psychoeducational programs, do not report any safety concerns, suggesting they are generally safe for humans. ^{1 2 3 4 5}

How is the Cognitive Enhancement Intervention treatment for epilepsy different from other treatments?

The Cognitive Enhancement Intervention for epilepsy is unique because it focuses on improving cognitive abilities, quality of life, and self-management through psychological and behavioral strategies, rather than directly targeting seizures like traditional drug treatments. ^{1 4 5 6 7}

What data supports the effectiveness of the treatment Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E, Lifestyle Interventions for Epilepsy?

Research shows that cognitive interventions, like memory enhancement courses and cognitive behavioral therapy, can improve memory, attention, and quality of life in people with epilepsy. These treatments help manage cognitive difficulties and improve mood, which are common challenges for those with epilepsy. ^{1 4 5 6 8}

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

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The effects of a brief memory enhancement course on individuals with epilepsy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A cognitive behavioral intervention (HOBSCOTCH) improves quality of life and attention in epilepsy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Memory rehabilitation and brain training for surgical temporal lobe epilepsy patients: a preliminary report. [2014]

4. England 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. [2015]

5. Switzerland 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Supporting Attention in Children with Epilepsy (SPACE): Pilot of a psychoeducational intervention. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of a self-regulation based psycho-educational pilot intervention targeting children and adolescents with epilepsy in Greece. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Subjective cognition is linked to everyday functioning in epilepsy. [2023]