A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability
Safety and Efficacy of a Deep Brain Stimulation System in Epilepsy: A Feasibility Study for Tracking Neural Excitability
1 other identifier
interventional
1
1 country
1
Brief Summary
The main purpose of this research project is to evaluate the safety and effectiveness of a surgically implanted device called the Medtronic Activa PC+S System in patients with medically refractory epilepsy (people who have seizures that are not completely controlled by medical therapy). The system sends small electrical pulses into a part of the brain called the thalamus to help control seizures. It sends this signal in regularly, regardless of if a seizure is occurring. A different version of this device is already approved for the treatment of epilepsy in Australia. This study aims to use the brain's responses to single pulse electrical stimulation to measure the level of seizure susceptibility. The investigators would like to show that this measure can be used to provide more effective deep brain stimulation therapies, to stop seizures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 14, 2018
CompletedStudy Start
First participant enrolled
March 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedOctober 27, 2020
October 1, 2020
2.3 years
March 7, 2018
October 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Seizure Rate
Comparing the number of seizures per patient, as recorded by Medtronic Activa PC+S system in the baseline vs. probe calibrated DBS phase.
Recorded throughout the baseline (2-4 months post implant) and probe calibrated DBS phase( 6-8 months post implant)
Secondary Outcomes (2)
Determine if probing responses provide a seizure susceptibility measure.
Throughout probing phase (4-6 months post implant)
Change in brain excitability following DBS treatment, assessed according to changes in probing response energy before and after stimulation therapy.
Throughout probing phase (4-6 months post implant) and probe calibrated DBS phase (6-8 months post implant).
Study Arms (5)
Recovery
NO INTERVENTIONTwo months recovery (no stimulation) following bilateral implantation of Medtronic PC+S devices into the anterior nucleus of the thalamus and the hippocampus. Thirty second EEG snapshots will be recorded every 15 minutes
Baseline
NO INTERVENTIONNo stimulation, 30 second EEG snapshots recorded every 15 minutes We require a minimum of 5 seizures to occur during this phase.
Probing
EXPERIMENTALDeep Brain Stimulation Electrically stimulate the thalamus continuously at a low frequency (2Hz). Thirty second EEG snapshots recorded every 15 minutes. We require a minimum of 5 seizures to occur during this phase.
Probe Calibrated Deep Brain Stimulation
EXPERIMENTALDeep Brain Stimulation In this phase we explore 18 deep brain stimulation parameter configurations (three stimulus intensities; 3,4,5 Volts, six different frequencies; 125 130, 135, 140,145, 150 Hz) during two of the clinic visits. Each deep brain stimulation parameter configuration will be tested for 1 minute with 4 minutes between each configuration test. The probing responses will be used to optimise the deep brain stimulation parameters for each participant. This phase of the study continues for 2 months.
Open Deep Brain Stimulation
EXPERIMENTALDeep Brain Stimulation During this phase the deep brain stimulation parameters may be altered from the probing optimised parameters according to patient needs.
Interventions
The device is called the Medtronic Activa PC+S system. Two devices will be implanted per participant. The electrodes will be surgically implanted bilaterally into the hippocampus and anterior nucleus of the thalamus.
Eligibility Criteria
You may qualify if:
- Patients with epilepsy with non-resectable pathologies, or clearly defined focal seizures without a defined structural pathology.
- Patients will be required to have a seizure diary (of up to 3 months) recording at least five seizures per month that are well separated in time (at least 8 hours apart).
You may not qualify if:
- Previous diagnosis of psychogenic/non-epileptic seizures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St Vincent's Hospital Melbournelead
- University of Melbournecollaborator
Study Sites (1)
St Vincent's Hospital Melbourne
Melbourne, Victora, 3065, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 7, 2018
First Posted
March 14, 2018
Study Start
March 27, 2018
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
October 27, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share