Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000687594
Ethics application status
Approved
Date submitted
26/04/2024
Date registered
30/05/2024
Date last updated
30/05/2024
Date data sharing statement initially provided
30/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-center study to investigate the utility of biosignals recorded during deep brain stimulation.
Scientific title
A multi-center study to investigate the utility of biosignals recorded during deep brain stimulation in adults.
Secondary ID [1] 311954 0
None
Universal Trial Number (UTN)
Trial acronym
UBR-DBS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 333551 0
Condition category
Condition code
Neurological 330237 330237 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants who are undergoing clinically indicated deep brain stimulation (DBS) surgery for implantation or revision purposes will have biosignals recorded during surgery. Biosignals will be measured from DBS electrodes using a custom-made neurostimulator and recording system. Connection to participants will use a one-time-use sterilised cable provided as standard-of-care and two disposable patch electrodes attached to skin below the shoulders. The customised device will be operated by a highly trained researcher. Collection of biosignals will take an additional 15-20 minutes throughout surgery where a surgery routinely takes 3-4 hours, although this can vary between treating teams. Stimulation is delivered in short 10 second bursts using similar parameters to those used for standard-of-care chronic therapy; balanced biphasic pulses with frequency less than 400 Hz and amplitude less than 9 milliamperes (typically 3.3 mA). DBS surgery will otherwise proceed as per standard of care which includes placing the participant under local or general anaesthetic, implantation of DBS leads into specific brain targets by the neurosurgeon, and performing intra operative imaging (CT scan) to confirm the location of DBS leads, or post DBS surgery if a CT scanner is not available in theatre. X-rays of the head are also performed during DBS surgery to confirm DBS leads location

As part of standard of care prior to and after surgery, medical imaging (MRI brain, CT brain) is collected for surgical planning and to confirm DBS electrode location/orientation. The pre-operative MRI brain scan prior to surgery takes an average of one hour, and the post operative CT scan takes an average of 15 minutes.

Participants will be recruited into one of two study arms:
Arm 1: Participants will exit the study following 7 days of observation after DBS surgery.
Arm 2: Participants will be supported through initial DBS programming sessions as per standard of care, with the initial program guided by biosignal data. Participants will continue to be observed for an additional 4 months and undergo standard of care assessments before exiting the study.

This study intends to enrol 300 participants in total (200 for Arm 1 and 100 for Arm 2).
There is no randomisation or pre-determined pattern to recruit participants into any given arm or sub-study. Once the required sample size for Arm 2 is reached, all subsequent participants will be recruited into Arm 1.

Relevant standard of care assessments, e.g. participant outcome measures and chronic DBS settings, may also be accessed from participant medical records up to 18 months post screening.

A group of participants in either Arm 1 or 2 may be invited into a sub-study where additional DBS programming testing will occur over two days at most.
Participants are eligible for the sub-study if they have been diagnosed with Parkinson's disease and have not had any complications from the DBS surgery (such as a malpositioned electrode) or any other issues which, in the opinion of the investigators, might compromise the participant’s ability to complete the protocol.
The sub study will occur 4 months post surgery. During these sessions, DBS programs will be temporarily changed by a movement disorder clinician and their symptoms assessed using routine assessment tools. At the conclusion of each session, participant's DBS program will be returned back to their usual DBS program. Each session will take approximately 4 to 5 hours.
Intervention code [1] 328414 0
Treatment: Devices
Intervention code [2] 328459 0
Treatment: Surgery
Comparator / control treatment
This study does not have a control group. There are no comparisons between Arm 1 and 2.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337987 0
Reliability of biosignal recordings from DBS electrodes under multiple conditions, such as biosignal recording strategies, hardware configurations and surgical conditions. All conditions will be assessed as a composite primary outcome.
Timepoint [1] 337987 0
Biosignals will be recorded during DBS surgery.
Secondary outcome [1] 433993 0
Main Study Secondary Outcome: Utility of biosignals to distinguish between different brain regions that surgeons are targeting for implantation.
Timepoint [1] 433993 0
Biosignals will be recorded during DBS surgery and imaging will be collected during their inpatient admission for surgery.
Secondary outcome [2] 433994 0
Main study Secondary Outcome: Change in chronic DBS therapy programs.
Timepoint [2] 433994 0
Baseline and up to 18 months from the date of eligible screening.
Secondary outcome [3] 434301 0
Sub study Outcome: Change in Parkinson's disease symptom severity as a result of different therapeutic configurations and settings, e.g. standard of care or biosignal based programs.
Timepoint [3] 434301 0
Assessments will be conducted as per standard of care requirements. All participants will have at least a baseline assessment, some will be assessed up to 4 months and some will also be assessed during an optional 2-day experimental programming session. Data may also be collected via participant medical records up to 18 months from the date of eligible screening.

Eligibility
Key inclusion criteria
Participants are eligible to be included in the study only if all the following criteria apply:
Participants aged 18 years or older at the time of recruitment into the study.
Participants who have planned to have deep brain stimulation surgery for the first time or participants who have previously been implanted with deep brain stimulation systems who are planning to undergo revision surgery to either add a DBS system, remove, replace, or reposition any component of the DBS system.
Participants who are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form

In addition to the above inclusion criteria, participants are eligible for the sub-study if the following criteria apply:
Participants who have been diagnosed with Parkinson’s disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are ineligible to be included in the study if one or more of the following criteria apply:
Participants with dementia, or a significant psychiatric, behavioural or any other issue which, in the opinion of the investigators, might significantly compromise their ability to understand or complete the study protocol.

In addition to the above exclusion criteria, participants will be excluded from the sub-study if the following criteria apply:
Any complications from the DBS surgery (such as a malpositioned electrode) or any other issue which, in the opinion of the investigators, might compromise the participant’s ability to complete the protocol.

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
1/06/2028
Actual
Date of last data collection
Anticipated
30/11/2029
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26397 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [2] 26398 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [3] 26399 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [4] 26400 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 42374 0
3065 - Fitzroy
Recruitment postcode(s) [2] 42375 0
3144 - Malvern
Recruitment postcode(s) [3] 42376 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 316293 0
Commercial sector/Industry
Name [1] 316293 0
Deep Brain Stimulation Technologies
Country [1] 316293 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Deep Brain Stimulation Technologies
Address
Country
Australia
Secondary sponsor category [1] 318480 0
None
Name [1] 318480 0
Address [1] 318480 0
Country [1] 318480 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315113 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 315113 0
Ethics committee country [1] 315113 0
Australia
Date submitted for ethics approval [1] 315113 0
14/03/2024
Approval date [1] 315113 0
28/03/2024
Ethics approval number [1] 315113 0
HREC 273/23

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

Contacts
Principal investigator
Name 133710 0
A/Prof Wesley Thevathasan
Address 133710 0
Deep Brain Stimulation Technologies, 166 Victoria Pde, East Melbourne, Victoria 3002
Country 133710 0
Australia
Phone 133710 0
+61 3 7045 0370
Fax 133710 0
Email 133710 0
[email protected]
Contact person for public queries
Name 133711 0
Prof Hugh McDermott
Address 133711 0
Deep Brain Stimulation Technologies, 166 Victoria Pde, East Melbourne, Victoria 3002
Country 133711 0
Australia
Phone 133711 0
+61 3 8508 8150
Fax 133711 0
Email 133711 0
[email protected]
Contact person for scientific queries
Name 133712 0
Prof Hugh McDermott
Address 133712 0
Deep Brain Stimulation Technologies, 166 Victoria Pde, East Melbourne, Victoria 3002
Country 133712 0
Australia
Phone 133712 0
+61 3 8508 8150
Fax 133712 0
Email 133712 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.