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A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability

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ClinicalTrials.gov Identifier: NCT03465163
Recruitment Status : Completed
First Posted : March 14, 2018
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
University of Melbourne
Information provided by (Responsible Party):
Mark Cook, St Vincent's Hospital Melbourne

Tracking Information
First Submitted Date  ICMJE March 7, 2018
First Posted Date  ICMJE March 14, 2018
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE March 27, 2018
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
  • 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.
  • 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). ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability
Official Title  ICMJE Safety and Efficacy of a Deep Brain Stimulation System in Epilepsy: A Feasibility Study for Tracking Neural Excitability
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Epilepsy
  • Nodular Heterotopia
Intervention  ICMJE 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.
Other Name: DBS
Study Arms  ICMJE
  • No Intervention: 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
  • No Intervention: Baseline
    No stimulation, 30 second EEG snapshots recorded every 15 minutes We require a minimum of 5 seizures to occur during this phase.
  • Experimental: 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.

    Intervention: Device: Deep Brain Stimulation
  • Experimental: 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.
    Intervention: Device: Deep Brain Stimulation
  • Experimental: 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.
    Intervention: Device: Deep Brain Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2020)
1
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2018)
5
Actual Study Completion Date  ICMJE July 1, 2020
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03465163
Other Study ID Numbers  ICMJE HREC/17/SVHM/146
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mark Cook, St Vincent's Hospital Melbourne
Study Sponsor  ICMJE St Vincent's Hospital Melbourne
Collaborators  ICMJE University of Melbourne
Investigators  ICMJE Not Provided
PRS Account St Vincent's Hospital Melbourne
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP