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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03465163




Registration number
NCT03465163
Ethics application status
Date submitted
7/03/2018
Date registered
14/03/2018

Titles & IDs
Public title
A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability
Scientific title
Safety and Efficacy of a Deep Brain Stimulation System in Epilepsy: A Feasibility Study for Tracking Neural Excitability
Secondary ID [1] 0 0
HREC/17/SVHM/146
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Nodular Heterotopia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Deep Brain Stimulation

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.

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.

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.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Seizure Rate
Timepoint [1] 0 0
Recorded throughout the baseline (2-4 months post implant) and probe calibrated DBS phase( 6-8 months post implant)
Secondary outcome [1] 0 0
Determine if probing responses provide a seizure susceptibility measure.
Timepoint [1] 0 0
Throughout probing phase (4-6 months post implant)
Secondary outcome [2] 0 0
Change in brain excitability following DBS treatment, assessed according to changes in probing response energy before and after stimulation therapy.
Timepoint [2] 0 0
Throughout probing phase (4-6 months post implant) and probe calibrated DBS phase (6-8 months post implant).

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous diagnosis of psychogenic/non-epileptic seizures

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2020
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
Victor
Recruitment hospital [1] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03465163