A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465163
• Other study ID #: HREC/17/SVHM/146
• Status: Completed
• Phase: N/A
• Start date: March 27, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: October 2020
• Source: St Vincent's Hospital Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Nodular Heterotopia

Intervention

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.

Locations

Country	Name	City	State
Australia	St Vincent's Hospital Melbourne	Melbourne	Victora

Sponsors (2)

Lead Sponsor	Collaborator
St Vincent's Hospital Melbourne	University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine if probing responses provide a seizure susceptibility measure.	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.	Throughout probing phase (4-6 months post implant)
Secondary	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).