A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability

Not Applicable

Completed

• Conditions: Nodular Heterotopia; Epilepsy

• Registration Number: NCT03465163
• Lead Sponsor: St Vincent's Hospital Melbourne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Study Start: 2018-03-27
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-25
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Seizure Rate	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 Outcome Measures

Name	Time	Method
Determine if probing responses provide a seizure susceptibility measure.	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.
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).

Trial Locations

Locations (1)

St Vincent's Hospital Melbourne; 🇦🇺 Melbourne, Victora, Australia