Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364085
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-03
Brief Title:
Enhancing Epilepsy Management With Precision Deep Brain Stimulation
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
EPI-BOOST Enhancing Epilepsy Management With Precision Deep Brain Stimulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPI-BOOST
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None