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A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability

NCT ID: NCT03465163

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-27

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy Nodular Heterotopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Recovery

Two 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

Group Type NO_INTERVENTION

No interventions assigned to this group

Baseline

No stimulation, 30 second EEG snapshots recorded every 15 minutes We require a minimum of 5 seizures to occur during this phase.

Group Type NO_INTERVENTION

No interventions assigned to this group

Probing

Deep 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.

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

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.

Probe Calibrated Deep Brain Stimulation

Deep 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.

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

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.

Open Deep Brain Stimulation

Deep Brain Stimulation During this phase the deep brain stimulation parameters may be altered from the probing optimised parameters according to patient needs.

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

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.

Interventions

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Deep Brain Stimulation

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.

Intervention Type DEVICE

Other Intervention Names

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DBS

Eligibility Criteria

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Inclusion Criteria

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).

Exclusion Criteria

Previous diagnosis of psychogenic/non-epileptic seizures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Melbourne

OTHER

Sponsor Role collaborator

St Vincent's Hospital Melbourne

OTHER

Sponsor Role lead

Responsible Party

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Mark Cook

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St Vincent's Hospital Melbourne

Melbourne, Victora, Australia

Site Status

Countries

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Australia

Other Identifiers

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HREC/17/SVHM/146

Identifier Type: -

Identifier Source: org_study_id