NCT05235061: HOBSCOTCHPTE

HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)

Active, enrolled NA Last updated 17 March 2026

What this trial tests

NA trial testing Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE) in Epilepsy, Traumatic in 160 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 March 2022

Primary endpoint
31 October 2025

1 December 2026

Quick facts

Lead sponsor	Dartmouth-Hitchcock Medical Center
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	160
Start date	21 March 2022
Primary completion	31 October 2025
Estimated completion	1 December 2026
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Epilepsy, Traumatic — all drugs for Epilepsy, Traumatic →
• Brain Injuries, Traumatic — all drugs for Brain Injuries, Traumatic →

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

18 and older, any sex, with Epilepsy, Traumatic or Brain Injuries, Traumatic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in quality of life as measured by comparing QOLIE-31 scores at baseline and 3 months post-intervention in participants with PTE
  Time frame: Baseline and 3 months post-intervention.
  The Quality of Life in Epilepsy (QOLIE-31) is a validated tool containing 16 multi-item scales which assess health related quality of life, emotional well-being, memory and attention deficits, medication effects, seizure control, psychosocial functioning, and health perception. Scores range from 0 to 100, with a higher score reflecting a higher quality of life.
• 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
  Time frame: Baseline, 3 months, 6 months
  The Cognitive Function sub-scale of the NeuroQOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
• 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
  Time frame: Baseline and 3 months post-intervention
  The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5 point Likert scale is used with a higher score indicating a greater level of perceived burden.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.