Home-Based Cognitive Training for Post-Traumatic Epilepsy

(HOBSCOTCHPTE Trial)

Overseen By Sarah J Kaden, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Dementing illness, Severe mental disability, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a home-based program can improve life quality and brain function for people with post-traumatic epilepsy (PTE). The program, called HOBSCOTCH-PTE (Home-Based Self-Management and Cognitive Training Changes Lives in post-traumatic epilepsy), includes virtual sessions and phone calls that teach skills for better symptom management. It also examines how this program might ease the burden on caregivers supporting someone with PTE. People with PTE who experience memory issues and have consistent internet and phone access could be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily life for those with PTE.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires no changes in your antiepileptic and antidepressant medication regimen for 1 month before joining. Brief discontinuation of antiepileptic medicine for inpatient video EEG evaluation is acceptable.

What prior data suggests that the HOBSCOTCH-PTE program is safe for participants and caregivers?

Research has shown that HOBSCOTCH-PTE is based on an existing program called HOBSCOTCH, which helps people with epilepsy manage memory and attention problems. This program has been used successfully in the past without major safety concerns. The current study aims to adapt it specifically for people with post-traumatic epilepsy (PTE) and their caregivers.

The original HOBSCOTCH program is known to be safe and well-tolerated. Since HOBSCOTCH-PTE is an adaptation, it is expected to be similarly safe. No reports of serious side effects have emerged with the original program. People using it have generally found it helpful and safe.

For caregivers, the program aims to reduce stress and improve their quality of life, highlighting its gentle and supportive nature. Since this trial is not testing a new drug but a behavioral program, the risks are considered low. Participants can feel reassured that the program's main focus is on improving mental skills and quality of life, not introducing new medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for post-traumatic epilepsy, which often focus on medication to control seizures, HOBSCOTCH-PTE offers a unique approach by emphasizing cognitive training and self-management. This method is delivered directly to participants' homes through a combination of webcam and telephone sessions, making it accessible and convenient. Researchers are excited because it includes caregivers in the process, offering them tools and relaxation techniques to better support the patient. This holistic approach aims to improve quality of life by addressing the cognitive and emotional challenges associated with epilepsy, beyond just seizure control.

What evidence suggests that the HOBSCOTCH-PTE program could be effective for improving quality of life in post-traumatic epilepsy?

Research shows that HOBSCOTCH-PTE could help people with post-traumatic epilepsy (PTE) live better and think more clearly. In this trial, participants in PTE Participant Group 1 will receive the HOBSCOTCH-PTE intervention immediately, while those in PTE Participant Group 2 will receive it after a 3-month wait. Users of this home-based program have reported improvements in daily life and mental sharpness. Studies also suggest it can ease depression and lift mood. For caregivers, early evidence indicates that HOBSCOTCH-PTE may help lower stress and enhance overall well-being. Caregivers in Group 1 will participate in the program alongside their PTE patients immediately, while those in Caregiver Group 2 will join after a 3-month wait. This program includes both learning and support sessions, which have made daily challenges easier for both patients and caregivers. ^{1 2 3 5 6}

Who Is on the Research Team?

Barbara Jobst, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Elaine T Kiriakopoulos, MD, MSc

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with post-traumatic epilepsy (PTE), who may have controlled or uncontrolled seizures and memory issues. Participants must not have changed their epilepsy or antidepressant medications in the last month, except for brief pauses for EEG tests. They should be able to read English and have access to a phone and internet.

Inclusion Criteria

I have epilepsy due to a past trauma, with seizures that may or may not be under control.

I feel like my memory is getting worse.

My epilepsy or depression medication hasn't changed in a month, except for EEG tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-HOBSCOTCH Session

Participants attend a pre-HOBSCOTCH session via webcam to prepare for the intervention

1 week

1 visit (virtual)

HOBSCOTCH-PTE Intervention

Participants receive the HOBSCOTCH-PTE intervention consisting of educational and telephone sessions to improve quality of life and cognitive function

8 weeks

1 educational session (virtual), 6 telephone sessions, 1 wrap-up session (virtual or telephone)

Follow-up

Participants are monitored for changes in quality of life, cognitive function, and caregiver burden post-intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• HOBSCOTCH-PTE for Caregivers
• Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)

Trial Overview The HOBSCOTCH-PTE program is being tested to see if it can help improve life quality and brain function in people with PTE, as well as ease the burden on their caregivers. It's a home-based self-management and cognitive training intervention designed specifically for those affected by PTE.

How Is the Trial Designed?

Group I: PTE Participant Group 2 Experimental Treatment 1 Intervention

PTE Participant Group 2 will be on a 3-month wait list after which they will receive HOBSCOTCH-PTE consisting of 1:1 sessions delivered once per week including: * 1 pre-HOBSCOTCH Session (on webcam) * 1 educational session (on webcam) * 6 telephone sessions * 1 wrap-up session (webcam or telephone)

Group II: PTE Participant Group 1 Experimental Treatment 1 Intervention

PTE Participant Group 1 will receive the HOBSCOTCH-PTE intervention consisting of 1:1 sessions delivered once per week including: * 1 pre-HOBSCOTCH Session (on webcam) * 1 educational session (on webcam) * 6 telephone sessions * 1 wrap-up session (webcam or telephone)

Group III: PTE Caregiver Group 2 Experimental Treatment 1 Intervention

Caregiver Group 2 will be on a 3 month wait list with their PTE patient after which time they will receive an adapted version of HOBSCOTCH-PTE by attending session 1 of the HOBSCOTCH-PTE (virtual) program with their PTE patient as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 2 will also attend session 8 of the program with the PTE patient to focus on program wrap-up and maintenance planning.

Group IV: PTE Caregiver Group 1 Experimental Treatment 1 Intervention

Caregiver Group 1 will receive an adapted version of HOBSCOTCH-PTE by attending session 1 of the HOBSCOTCH-PTE (virtual) program with their PTE patient as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 1 will also attend session 8 of the program with the PTE patient to focus on program wrap-up and maintenance planning.

HOBSCOTCH-PTE for Caregivers is already approved in United States for the following indications:

Approved in United States as HOBSCOTCH for:

• Improvement of quality of life and cognitive function in individuals with post-traumatic epilepsy (PTE)
• Reduction of caregiver burden

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

In a study of 62 severe traumatic brain injury patients, specific early quantitative EEG (qEEG) features, such as increased delta frequency power and delta:theta power ratio, were identified as predictors for the development of posttraumatic epilepsy (PTE), which can occur months to years after injury.

The predictive models developed in this study, with an area under the curve of 0.76, suggest that analyzing early EEG data can help identify patients at high risk for PTE, potentially improving early clinical management and guiding future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting posttraumatic epilepsy using admission electroencephalography after severe traumatic brain injury. Pease, M., Elmer, J., Shahabadi, AZ., et al.[2023]

Home-based cognitive training for patients with acquired brain injury can enhance the intensity of rehabilitation, leading to better outcomes in cognitive recovery.

This approach allows for improved generalization of skills learned during formal training to everyday activities, making it easier for patients to utilize their pre-existing cognitive strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home and family in cognitive rehabilitation after brain injury: Implementation of social reserves. Mogensen, J., Wulf-Andersen, C.[2018]

Posttraumatic epilepsy (PTE) is a significant long-term complication of traumatic brain injury (TBI), with varying risks depending on the type of injury; for example, veterans with penetrating TBI have a 53% risk of developing PTE, while the risk is lower (10-25%) for combat-related closed-head trauma with brain imaging.

Effective seizure control is crucial for veterans with TBI, as uncontrolled epilepsy can lead to serious consequences such as accidents, social stigma, and challenges in employment, highlighting the need for proper diagnosis and treatment to improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic epilepsy and treatment. Chen, JW., Ruff, RL., Eavey, R., et al.[2021]

This study aims to explore the health and quality of life of veterans with posttraumatic epilepsy (PTE) and their caregivers, comparing them to veterans without PTE, through a prospective cohort study involving multiple groups and various data collection methods.

The research will identify the specific needs and challenges faced by caregivers of veterans with PTE, which is crucial for informing treatment plans and support services, as current knowledge about the caregiver's impact on both their health and the veterans' health is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military Injuries-Understanding Posttraumatic Epilepsy, Health, and Quality-of-Life Effects of Caregiving: Protocol for a Longitudinal Mixed Methods Observational Study. Bouldin, ED., Delgado, R., Peacock, K., et al.[2022]

The number of individuals with early brain injury and epilepsy being discharged into the community has increased, highlighting a growing need for specialized care and support services.

Common challenges faced by these patients include a lack of specialized services, caregiver knowledge gaps, and unrealistic expectations, emphasizing the importance of effective communication and ongoing education for caregivers to improve seizure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizures in the de-institutionalized patients with early brain injuries. DeToledo, JC.[2019]

Post-traumatic amnesia (PTA) is a complex condition following traumatic brain injury (TBI) that involves not only disrupted memory but also significant cognitive deficits, including attention and executive functioning impairments, which are often overlooked in current assessment scales.

The Westmead PTA scale (WPTAS), commonly used in Australasia for managing TBI, has been found to have limitations in its validity, suggesting that it may not fully capture the extensive cognitive and behavioral disturbances associated with PTA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-traumatic amnesia. Marshman, LA., Jakabek, D., Hennessy, M., et al.[2013]

Engaging in the online patient community PatientsLikeMe for at least 6 weeks significantly improved self-management and self-efficacy in veterans with epilepsy, as shown by validated questionnaire scores.

The most notable improvement was in information management behaviors, indicating that online support can enhance how veterans manage their epilepsy effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients optimizing epilepsy management via an online community: the POEM Study. Hixson, JD., Barnes, D., Parko, K., et al.[2018]

In a study of 238 head trauma patients over six years, 87 were identified with posttraumatic epilepsy (PTE), showing that while PTE patients had lower functional levels at admission and discharge, they still made significant rehabilitation gains during hospitalization.

PTE patients required more nursing care upon discharge compared to non-PTE patients, indicating that while PTE does not hinder rehabilitation progress, it does affect the planning for care after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation outcomes in patients with posttraumatic epilepsy. Armstrong, KK., Sahgal, V., Bloch, R., et al.[2019]

The MINUTE study, involving 2603 post-9/11 veterans, found high rates of undocumented mild traumatic brain injuries (mTBI) among veterans with epilepsy, highlighting the challenges in tracking TBI histories in health records.

Veterans with both epilepsy and TBI reported worse physical functioning and health-related quality of life compared to those with either condition alone, indicating a need for targeted interventions to support this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Military Injuries: Understanding Post-Traumatic Epilepsy Study: Understanding Relationships among Lifetime Traumatic Brain Injury History, Epilepsy, and Quality of Life. Pugh, MJ., Kennedy, E., Gugger, JJ., et al.[2023]

A home care model significantly improved coping styles and treatment compliance in 144 patients recovering from postcranial surgery complicated by epilepsy, compared to standard nursing interventions.

Patients receiving the home care model reported better quality of life, including higher scores in social functioning, emotional well-being, and energy levels after 6 months of follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Home Care Interventions in Patients with Moderate to Severe Craniocerebral Injury Combined with Epilepsy. Zhang, LL., Jiang, ZJ., Li, YY., et al.[2022]

Older adults experience the highest rates of traumatic brain injury (TBI) incidents, leading to significant emergency visits, hospitalizations, and mortality, yet many can benefit from aggressive management and rehabilitation despite assumptions of futility based on age and injury severity.

There is a critical need for more research focused on geriatric TBI, including the development of specific guidelines and prognostic models, as current approaches often overlook the unique health factors of older adults that may better predict outcomes than age alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric Traumatic Brain Injury: Epidemiology, Outcomes, Knowledge Gaps, and Future Directions. Gardner, RC., Dams-O'Connor, K., Morrissey, MR., et al.[2021]

The TF-CBT Web program, a web-based training for Trauma Focused Cognitive Behavioral Therapy, was successfully registered by 4,020 healthcare professionals, showing significant knowledge gains and high user satisfaction.

The training program was well-received and deemed relevant for clinical practice, indicating that web-based training can effectively enhance the skills of mental health practitioners in treating PTSD in children and youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online training for evidence-based child trauma treatment: evaluation of the German language TF-CBT-Web. Kasparik, B., Saupe, LB., Mäkitalo, S., et al.[2022]

Acquired brain injury (ABI) not only impacts the patient but also significantly affects their family, highlighting the need for therapeutic approaches that include family support.

Supplementing institution-based cognitive rehabilitation with home-based training can enhance recovery outcomes, but it also poses challenges for family dynamics and psychological well-being, suggesting a need for family-based intervention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family and home in cognitive rehabilitation after brain injury: The importance of family oriented interventions. Wulf-Andersen, C., Mogensen, J.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05235061?term=AREA%5BConditionSearch%5D(%22Epilepsy,%20Post-Traumatic%22)&rank=7

HOme-Based Self-management and COgnitive Training ... This study will also assess the ability of the HOBSCOTCH-PTE program to improve quality of life in caregivers of PTE patients and to reduce caregiver burden.

2. bolderscience.com bolderscience.com/trialdetails.html?nctid=NCT05235061

Post-Traumatic Epilepsy (PTE) This study will also assess the ability of the HOBSCOTCH-PTE program to improve quality of life in caregivers of PTE patients and to reduce caregiver burden.

3. cureepilepsy.org cureepilepsy.org/wp-content/uploads/2021/11/Post-Traumatic-and-Cognitive-Training-Improving-Quality-of-Life-Through-HOBSCOTCH-webinar.pdf

Post-Traumatic and Cognitive Training: Improving Quality ... This webinar will also provide details about a program called HOBSCOTCH, or the Home-Based Self-Management and Cognitive. Training Changes Lives program.

4. aesnet.org aesnet.org/abstractslisting/hobscotch-adapted-for-post-traumatic-epilepsy-impact-on-quality-of-life-depression-and-suicidality

hobscotch adapted for post traumatic epilepsy: impact on ... This project examines efficacy of the adapted, HOBSCOTCH-PTE (HOme Based Self-Management and COgnitive Training CHanges Lives in Post ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9169940/

Effectiveness of a Self-Management Program to Improve ... Home-Based Self-Management and Cognitive Training Changes Lives (HOBSCOTCH) is an epilepsy self-management program developed within the MEW Network that ...

6. aesnet.org aesnet.org/clinical-care/epilepsy-self-management/self-management-programs/hobscotch

HOBSCOTCH (Home Based Self-Management and Cognitive ... HOBSCOTCH is an evidence-based self-management program designed to address memory and attention problems in adults with epilepsy.