Enhancing Epilepsy Management With Precision Deep Brain Stimulation
EPI-BOOST
EPI-BOOST: Enhancing Epilepsy Management With Precision Deep Brain Stimulation
1 other identifier
interventional
40
1 country
1
Brief Summary
The goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (DBS) programming for drug-resistant epilepsy in a prospective observational cohort study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2024
CompletedFirst Posted
Study publicly available on registry
April 15, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedApril 15, 2024
April 1, 2024
1.6 years
April 3, 2024
April 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seizure reduction
The number of seizures experienced by patients will be assessed by the number of seizures recorded by patients and their caregivers in seizure diaries and described as absolute seizure reduction.
Change from baseline versus Month 12
Secondary Outcomes (3)
Change in disease score on Patient Weighted Quality Of Life In Epilepsy
Twelve months
Change in depression score on Neurological Disorders Depression Inventory in Epilepsy
Twelve months
Change in anxiety score on Anxiety General Anxiety Disorder-7
Twelve months
Study Arms (1)
Participant Group
EXPERIMENTALParticipants who meet eligibility criteria and provide informed consent.
Interventions
Participants will be brought in for their standard follow-up appointments at 4-weeks, 4-months, and 1-year post-surgery. In addition to the routine care, physiological data will be extracted from the implanted device and analyzed. The physiological data will be considered along with the standard epilepsy diary to assess epileptic burden and inform device programming. Quality of life will be measured with a series of standard questionnaires pre-surgery and at the 1-year follow-up.
Eligibility Criteria
You may qualify if:
- Patients qualifying for deep brain stimulation on the basis of drug-resistant epilepsy
- Informed consent
You may not qualify if:
- Lack of consent
- Electrical or other devices that preclude the performance of an MRI for pre-operative imaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Elizabeth Health Science Centre
Halifax, Nova Scotia, B3H 3A7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lutz Weise, MD, PhD
Dalhousie University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 3, 2024
First Posted
April 15, 2024
Study Start
June 1, 2024
Primary Completion
January 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 15, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share