Clinical trial NCT06364085: Enhancing Epilepsy Management With Precision Deep Brain Stimulation
Official title: EPI-BOOST: Enhancing Epilepsy Management With Precision Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy, Drug Resistant
Keywords: Deep brain stimulation
DBS Programming
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Aim 1: To objectively monitor epilepsy burden with the provided sensing capabilities of the DBS leads by quantifying the association between neuronal activity and seizure frequency

Aim 2: To use the neuronal activity to inform programming of DBS for patients with epilepsy, and assess the impact on patient and caregiver quality of life and hospital costs.

Epilepsy is a neurological disorder characterized by recurrent, unprovoked seizures that affects millions of individuals worldwide and poses a significant burden on their quality of life. Despite considerable advancements in treatment strategies, approximately one-third of patients are considered to have drug-resistant epilepsy. Patients with drug-resistant epilepsy frequently visit the emergency room, are hospitalized regularly, and have many seizure-related injuries. Deep brain stimulation (DBS) offers a unique treatment option by delivering precise electrical pulses with surgically implanted electrodes to the specific brain regions responsible for seizures, disrupting the seizure pathways. Long-term favorable findings showing significant seizure reduction at five-year post-implantation for patients who otherwise have no treatment options have convinced many centers to incorporate DBS into their healthcare practise.

For assessing the treatment response in epilepsy, healthcare providers are dependent on patient-reported seizure diaries. Recent research in DBS has focused on the biological implications of neuronal recordings through the implanted electrodes. These signals offer objective insight into brain activity, specifically epileptic burden, and offers potentially predictive capabilities. Current research focuses on whether the sensing capabilities of DBS can provide reliable seizure burden detection, and whether this can be achieved with less demand on the patient.

In this prospective observational cohort study, the researchers aim to improve the impact of DBS treatment on the seizure burden and quality of life of patients diagnosed with drug-resistant epilepsy in Atlantic Canada. This will be done by investigating the neural activity underlying epileptic events as a representation of epileptic burden, affording the opportunity to tailor DBS interventions with more precision and efficiency.

Eligibility criteria: Inclusion Criteria:

* Patients qualifying for deep brain stimulation on the basis of drug-resistant epilepsy
* Informed consent

Exclusion Criteria:

* Lack of consent
* Electrical or other devices that preclude the performance of an MRI for pre-operative imaging

Primary outcomes:
measure: Seizure reduction
timeFrame: Change from baseline versus Month 12
Secondary outcomes:
measure: Change in disease score on Patient Weighted Quality Of Life In Epilepsy
timeFrame: Twelve months
measure: Change in depression score on Neurological Disorders Depression Inventory in Epilepsy
timeFrame: Twelve months
measure: Change in anxiety score on Anxiety General Anxiety Disorder-7
timeFrame: Twelve months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth Health Science Centre
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Lutz Weise, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: