Enhancing Epilepsy Management With Precision Deep Brain Stimulation
NCT ID: NCT06364085
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-06-30
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participant Group
Participants who meet eligibility criteria and provide informed consent.
Neuromodulation programming
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.
Interventions
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Neuromodulation programming
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
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Inclusion Criteria
* Informed consent
Exclusion Criteria
* Electrical or other devices that preclude the performance of an MRI for pre-operative imaging
ALL
No
Sponsors
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Nova Scotia Health Authority
OTHER
Responsible Party
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Lutz Weise
Principal Investigator
Principal Investigators
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Lutz Weise, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dalhousie University
Locations
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Queen Elizabeth Health Science Centre
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Lutz Weise
Role: primary
Other Identifiers
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DBS2024
Identifier Type: -
Identifier Source: org_study_id
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