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Home-Based Cognitive Training for Post-Traumatic Epilepsy (HOBSCOTCHPTE Trial)

N/A
Recruiting
Led By Barbara C. Jobst, MD, Dr. Med.
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of post traumatic epilepsy, with controlled or uncontrolled seizures
Literate and proficient in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

Summary

This trial will test whether the HOBSCOTCH-PTE program can improve quality of life and cognitive function in people with post traumatic epilepsy, as well as reduce caregiver burden.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-medical interventions like self-management techniques and cognitive exercises, there are no direct medical side effects expected from participating in HOBSCOTCH-PTE itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have epilepsy due to a past trauma, with seizures that may or may not be under control.
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I can read and speak English well.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 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 caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention in caregivers of PTE participants
Change in quality of life as measured by comparing QOLIE-31 scores at baseline and 3 months post-intervention in participants with PTE
Change in subjective cognition as measured by comparing NeuroQOL - Cognitive Function sub-scale scores at baseline and 3 months post-intervention in participants with PTE
Secondary study objectives
Changes in Caregiver Participants' knowledge of epilepsy as measured by comparing scores on the [Caregiver] General Knowledge of Epilepsy questionnaire at baseline and at 6 months-post intervention.
Changes in Caregiver Participants' mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.
Changes in PTE Participants' mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.
+14 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: PTE Participant Group 2Experimental Treatment1 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 1Experimental Treatment1 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 2Experimental Treatment1 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 1Experimental Treatment1 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.

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
536 Previous Clinical Trials
2,539,497 Total Patients Enrolled
United States Department of DefenseFED
891 Previous Clinical Trials
332,288 Total Patients Enrolled
Barbara C. Jobst, MD, Dr. Med.Principal InvestigatorDartmouth-Hitchcock Medical Center
~17 spots leftby Jan 2025
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