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Neuromodulation
Deep Brain Stimulation for Epilepsy (EPI-BOOST Trial)
N/A
Waitlist Available
Led By Lutz Weise, MD, PhD
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up twelve months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using objective neural response feedback can improve the programming of deep brain stimulation for epilepsy that doesn't respond to medication.
Who is the study for?
This trial is for individuals with drug-resistant epilepsy who have consented to participate and qualify for deep brain stimulation (DBS). It's not suitable for those who cannot undergo an MRI due to electrical or other devices in their body.
What is being tested?
The study is testing how effective it is to use objective neural response feedback when setting up DBS programming for managing drug-resistant epilepsy, in a forward-looking observational group of patients.
What are the potential side effects?
While the information provided does not specify side effects, generally, DBS can lead to headache, seizure, infection at the implant site, and temporary pain or swelling where the device was implanted.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline versus month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline versus month 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Seizure reduction
Secondary study objectives
Change in anxiety score on Anxiety General Anxiety Disorder-7
Change in depression score on Neurological Disorders Depression Inventory in Epilepsy
Change in disease score on Patient Weighted Quality Of Life In Epilepsy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participant GroupExperimental Treatment1 Intervention
Participants who meet eligibility criteria and provide informed consent.
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Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
287 Previous Clinical Trials
94,282 Total Patients Enrolled
2 Trials studying Epilepsy
325 Patients Enrolled for Epilepsy
Lutz Weise, MD, PhDPrincipal InvestigatorDalhousie University
2 Previous Clinical Trials
104 Total Patients Enrolled
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