Enhancing Epilepsy Management With Precision Deep Brain Stimulation

Epilepsy, Drug Resistant Clinical Trial

— EPI-BOOST  

Official title:

EPI-BOOST: Enhancing Epilepsy Management With Precision Deep Brain Stimulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364085
• Other study ID #: DBS2024
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Epilepsy, Drug Resistant

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Queen Elizabeth Health Science Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure reduction	The number of seizures experienced by patients will be assessed by the number of seizures recorded by patients and their caregivers in seizure diaries and described as absolute seizure reduction.	Change from baseline versus Month 12
Secondary	Change in disease score on Patient Weighted Quality Of Life In Epilepsy	Assessment of therapeutic effects using Patient Weighted Quality Of Life In Epilepsy, a 10-question survey completed by patients to assess quality of life, where a higher score is associated with a more positive quality of life.	Twelve months
Secondary	Change in depression score on Neurological Disorders Depression Inventory in Epilepsy	Assessment of therapeutic effects using Neurological Disorders Depression Inventory in Epilepsy, a 6-question survey to assess depression. A higher score is associated with more severe depression.	Twelve months
Secondary	Change in anxiety score on Anxiety General Anxiety Disorder-7	Assessment of therapeutic effects using Anxiety General Anxiety Disorder-7, a 7-question survey to assess anxiety. A higher score is associated with more severe anxiety, and a lower score is associated with minimal anxiety.	Twelve months