NCT03465163

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: St Vincent's Hospital Melbourne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy
• Nodular Heterotopia

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2018-03-27
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2018-03-14
• Last updated: 2020-10-27

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study