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Completed

NCT Number: NCT03465163

A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Nodular Heterotopia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Vincent's Hospital Melbourne

Melbourne, Victora, 3065, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

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.

Other names: DBS

Primary outcomes

  1. Change in Seizure Rate

    Time frame: Recorded throughout the baseline (2-4 months post implant) and probe calibrated DBS phase( 6-8 months post implant)

    Comparing the number of seizures per patient, as recorded by Medtronic Activa PC+S system in the baseline vs. probe calibrated DBS phase.

Secondary outcomes

  1. Determine if probing responses provide a seizure susceptibility measure.

    Time frame: Throughout probing phase (4-6 months post implant)

    Calculate probability of seizure in the near future given the features of the probing response shape during pre-ictal and inter-ictal periods on training dataset and then test predictive power on remaining data. Features defining the probing response shape will include peak amplitude and peak latency. Seizure occurrences will be determined by the Medtronic PC+S device.

  2. Change in brain excitability following DBS treatment, assessed according to changes in probing response energy before and after stimulation therapy.

    Time frame: Throughout probing phase (4-6 months post implant) and probe calibrated DBS phase (6-8 months post implant).

Sponsors and collaborators

Lead sponsor

St Vincent's Hospital Melbourne

Other

Collaborators

  • University of Melbourne

Registry information

Official study title

Safety and Efficacy of a Deep Brain Stimulation System in Epilepsy: A Feasibility Study for Tracking Neural Excitability

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2018
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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