Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06364085 |
Other study ID # |
DBS2024 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 2024 |
Est. completion date |
June 2026 |
Study information
Verified date |
April 2024 |
Source |
Nova Scotia Health Authority |
Contact |
Lutz Weise, MD, PhD |
Phone |
902-472-6850 |
Email |
lutz.weise[@]nshealth.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.