Enhancing Epilepsy Management With Precision Deep Brain Stimulation (EPI-BOOST)

N

Nova Scotia Health Authority (NSHA)

Status

Begins enrollment this month

Conditions

Epilepsy, Drug Resistant

Treatments

Device: Neuromodulation programming

Study type

Interventional

Funder types

Other

Identifiers

NCT06364085
DBS2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Participant Group
Experimental group
Description:
Participants who meet eligibility criteria and provide informed consent.
Treatment:
Device: Neuromodulation programming

Trial contacts and locations

1

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Central trial contact

Lutz Weise, MD, PhD

Data sourced from clinicaltrials.gov

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