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

190 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-PTE, to improve the quality of life and cognitive function in Service Members, Veterans and civilians with 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.

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 data supports the effectiveness of the treatment HOBSCOTCH-PTE for post-traumatic epilepsy?

The study on home care interventions for patients with epilepsy suggests that home-based models can improve coping styles and quality of life, which may support the potential effectiveness of HOBSCOTCH-PTE as a home-based treatment for post-traumatic epilepsy. ^{1 2 3 4 5}

Is home-based cognitive training safe for humans?

The research does not provide specific safety data for home-based cognitive training, but it suggests that such training can be integrated into daily life, potentially enhancing rehabilitation without indicating any safety concerns. ^{6 7 8 9 10}

How is the HOBSCOTCH-PTE treatment different from other treatments for post-traumatic epilepsy?

HOBSCOTCH-PTE is unique because it is a home-based program that focuses on self-management and cognitive training, which can empower patients and caregivers to manage post-traumatic epilepsy more effectively, unlike traditional treatments that primarily rely on medication. ^{3 4 11 12 13}

Research Team

Barbara Jobst, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Elaine T Kiriakopoulos, MD, MSc

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Effectiveness of Home Care Interventions in Patients with Moderate to Severe Craniocerebral Injury Combined with Epilepsy. [2022]

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

Patients optimizing epilepsy management via an online community: the POEM Study. [2018]

3. Canada 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. [2022]

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

Posttraumatic epilepsy and treatment. [2021]

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

Rehabilitation outcomes in patients with posttraumatic epilepsy. [2019]

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

Geriatric Traumatic Brain Injury: Epidemiology, Outcomes, Knowledge Gaps, and Future Directions. [2021]

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

Online training for evidence-based child trauma treatment: evaluation of the German language TF-CBT-Web. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Home and family in cognitive rehabilitation after brain injury: Implementation of social reserves. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Family and home in cognitive rehabilitation after brain injury: The importance of family oriented interventions. [2018]

10. Scotland pubmed.ncbi.nlm.nih.gov

Post-traumatic amnesia. [2013]

11. England pubmed.ncbi.nlm.nih.gov

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

12. United States 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. [2023]

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

Predicting posttraumatic epilepsy using admission electroencephalography after severe traumatic brain injury. [2023]