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Trial registered on ANZCTR


Registration number
ACTRN12621001369819
Ethics application status
Approved
Date submitted
5/08/2021
Date registered
11/10/2021
Date last updated
15/08/2022
Date data sharing statement initially provided
11/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical feasibility study to evaluate the Bionics Institute Rigidity Device (BiRD) at quantifying motor symptoms in people with Parkinson’s disease.
Scientific title
A clinical feasibility study to evaluate the Bionics Institute Rigidity Device (BiRD) at quantifying motor symptoms in people with Parkinson’s disease.
Secondary ID [1] 304920 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 323064 0
Condition category
Condition code
Neurological 320643 320643 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Bionics Institute Rigidity Device (BiRD) is an instrumented device worn on the palm of the hand. A miniature motor flexes and extends the third digit while a force sensor measures the force required to achieve range of movement. An onboard inertial measurement unit tracks movement of the hand.

Two cohorts of participants with Parkinson's disease will be recruited into the study:
1. Participants with Parkinson's disease predominantly treated with medication, who are undergoing an anti-Parkinsonian medication withdrawal challenge as part of their standard clinical care.
2. Participants with Parkinson's disease predominantly treated with bilateral deep brain stimulation (DBS) located in the subthalamic nucleus region.

Each participant will attend a single study visit, no follow-up visits are required. Research team members trained to operate the BiRD will provide instructions and assist participants through all assessments. During each assessment, participants will be asked to make a series of postures and movements as guided by standard clinical tests while wearing the device. Depending on the participant cohort, participants with Parkinson's disease will be assessed using the BiRD under the following conditions:
1. Participants with Parkinson's disease predominantly treated with medication will be assessed following an overnight withdrawal of medication. This session should last no longer than 1.5 hours and may be conducted in the clinic as an adjunct to their outpatient appointment.
2. Participants with Parkinson's disease predominantly treated with DBS will be assessed under multiple conditions: without DBS therapy, with their standard DBS therapy, and at pre-defined DBS stimulation amplitudes. A maximum of 12 DBS stimulation amplitudes will be investigated, with each stimulation intensity incremented after a nominated time interval (no longer than 10 minutes). Each stimulation increment will include a short wash-in period and a BiRD assessment. Participants may rest during any additional time prior to the scheduled stimulation increment. This session should last no longer than 3.5 hours and will be conducted at a research institution.
Intervention code [1] 321315 0
Diagnosis / Prognosis
Intervention code [2] 321324 0
Early detection / Screening
Comparator / control treatment
All participants with Parkinson's disease will be assessed with Part III of the Unified Parkinson's Disease Rating Scale (UPDRS), a clinical tool used to quantify the motor symptoms of Parkinson's disease. Clinical assessment will occur at the same timepoints as the BiRD assessments, as outlined above:
1. Participants with Parkinson's disease predominantly treated with medication will be assessed following an overnight withdrawal of medication.
2. Participants with Parkinson's disease predominantly treated with DBS will be assessed without DBS therapy, with their standard DBS therapy, and at varying DBS stimulation amplitudes. However, only a subset of test items will be used to clinically assess participant at each DBS stimulation increment.

A cohort of healthy volunteers will also be assessed using the BiRD. Healthy volunteers will be asked to perform an identical series of postures and movements compared to participants with Parkinson’s disease. Additional postures may also be investigated and electromyography of muscles controlling finger flexion and extension will be collected.
Control group
Active

Outcomes
Primary outcome [1] 328456 0
Validity of the BiRD assessing rigidity severity in people with Parkinson's disease, e.g. correlation with rigidity-related item(s) of the UPDRS.
Timepoint [1] 328456 0
Rigidity assessments are conducted in participants with Parkinson's disease following overnight withdrawal of medication (at least 8 hours since last medication dosage) and/or withdrawal of DBS therapy (at least 45 minutes).
Primary outcome [2] 328476 0
Dose-response curve of rigidity severity assessed using the BiRD to DBS stimulation intensities.
Timepoint [2] 328476 0
Participants with Parkinson's disease predominantly treated with DBS will be assessed following no more than 12 pre-defined incremental increases in DBS stimulation amplitude, for example, 0.5mA, 1mA, 1.5mA, 2mA, etc.
Secondary outcome [1] 399083 0
Validity of the BiRD assessing bradykinesia severity in people with Parkinson's disease, e.g. correlation with bradykinesia-related item(s) of the UPDRS.
Timepoint [1] 399083 0
Bradykinesia assessments are conducted in participants with Parkinson's disease following overnight withdrawal of medication (at least 8 hours since last medication dosage) and/or withdrawal of DBS therapy (at least 45 minutes).
Secondary outcome [2] 400349 0
Validity of the BiRD assessing tremor severity in people with Parkinson's disease, e.g. correlation with tremor-related item(s) of the UPDRS.
Timepoint [2] 400349 0
Tremor assessments are conducted in participants with Parkinson's disease following overnight withdrawal of medication (at least 8 hours since last medication dosage) and/or withdrawal of DBS therapy (at least 45 minutes).
Secondary outcome [3] 400351 0
Dose-response curve of bradykinesia severity assessed using the BiRD to DBS stimulation intensities.
Timepoint [3] 400351 0
Participants with Parkinson's disease predominantly treated with DBS will be assessed following no more than 12 pre-defined incremental increases in DBS stimulation amplitude, for example, 0.5mA, 1mA, 1.5mA, 2mA, etc.
Secondary outcome [4] 400352 0
Dose-response curve of tremor severity assessed using the BiRD to DBS stimulation intensities.
Timepoint [4] 400352 0
Participants with Parkinson's disease predominantly treated with DBS will be assessed following no more than 12 pre-defined incremental increases in DBS stimulation amplitude, for example, 0.5mA, 1mA, 1.5mA, 2mA, etc.
Secondary outcome [5] 401264 0
Within session reliability of the BiRD at quantifying the severity of rigidity in participants with Parkinson's disease.
Timepoint [5] 401264 0
Consecutive assessments in participants with Parkinson's disease following overnight withdrawal of medication (at least 8 hours since last medication dosage) and/or withdrawal of DBS therapy (at least 45 minutes).
Secondary outcome [6] 401265 0
Within-session reliability of the BiRD at quantifying the severity of bradykinesia in participants with Parkinson's disease.
Timepoint [6] 401265 0
Consecutive assessments in participants with Parkinson's disease following overnight withdrawal of medication (at least 8 hours since last medication dosage) and/or withdrawal of DBS therapy (at least 45 minutes).
Secondary outcome [7] 401266 0
Within-session reliability of the BiRD at quantifying the severity of tremor in participants with Parkinson's disease.
Timepoint [7] 401266 0
Consecutive assessments in participants with Parkinson's disease following overnight withdrawal of medication (at least 8 hours since last medication dosage) and/or withdrawal of DBS therapy (at least 45 minutes).

Eligibility
Key inclusion criteria
All participants with Parkinson's disease:
* Have a diagnosis of Parkinson's disease by a neurologists as per the UK Parkinson's Disease Brain Bank Diagnostic Criteria
* Are capable of providing informed consent
* Are capable of attending the research site for data collection.

Participants with Parkinson's disease who are primarily treated with deep brain stimulation:
* Have deep brain stimulation electrodes implanted bilaterally into the subthalamic nucleus region
* Experience stable management, defined as no changes to medication or DBS program for a period of two months prior to data collection.

Healthy volunteers:
* Are in good general health
* Are capable of providing informed consent
* Are capable of attending the research site.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All participants with Parkinson's disease:
* Have a significantly limited range of movement at the metacarpal joints
* Have a known or suspected diagnosis of bone disease that affects the upper limb
* Have a known or suspected diagnosis of joint disorder that affects the upper limb
* Have a disease or disorder affecting the neuromuscular system
* Previous surgical intervention to hand or finger, including amputation
* Previous history of brain surgery other than DBS implantation
* Comorbidities affecting rigidity, tremor, bradykinesia.

Participants with Parkinson's disease predominantly treated with DBS:
* Implanted with DBS less than three months prior to data collection.

Healthy volunteers:
* Have a limited range of movement at the metacarpal joints
* Have a known or suspected diagnosis of bone disease that affects the upper limb
* Have a known or suspected diagnosis of joint disorder that affects the upper limb
* Have a disease or disorder affecting the neuromuscular system
* Previous surgical intervention to hand or finger, including amputation
* Previous history of brain surgery
* Current prescription of medication known to cause changes in muscle tone, tremor, balance or other movement problems.

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Clinical assessors of participants with Parkinson's disease predominantly treated by DBS will be blinded to DBS stimulation intensities.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To address our primary objective of evaluating the clinical feasibility of the BiRD, a correlation could be conducted with the extracted features aimed at quantifying rigidity, tremor and bradykinesia, and clinical scores obtained from the relevant clinical rating scale items. An ANOVA may be used to determine whether objective measures are significantly different between clinical assessments of rigidity. A dose-response curve may also be generated to demonstrate the relationship between objective measures and/or clinical scores with each investigated DBS stimulation amplitude.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/10/2021
Actual
20/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20121 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [2] 20122 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 20137 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 34831 0
3144 - Malvern
Recruitment postcode(s) [2] 34832 0
3084 - Heidelberg
Recruitment postcode(s) [3] 34860 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 309299 0
Charities/Societies/Foundations
Name [1] 309299 0
AMP Foundation
Country [1] 309299 0
Australia
Funding source category [2] 309316 0
Charities/Societies/Foundations
Name [2] 309316 0
Bethlehem Griffiths Foundation
Country [2] 309316 0
Australia
Funding source category [3] 309318 0
Hospital
Name [3] 309318 0
St Vincent's Hospital Research Endowment Fund
Country [3] 309318 0
Australia
Funding source category [4] 309319 0
Charities/Societies/Foundations
Name [4] 309319 0
Bionics Institute Incubator Fund
Country [4] 309319 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Bionics Institute
Address
384-388 Albert Street, East Melbourne, VIC 3002
Country
Australia
Secondary sponsor category [1] 310272 0
None
Name [1] 310272 0
Address [1] 310272 0
Country [1] 310272 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309130 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 309130 0
Ethics committee country [1] 309130 0
Australia
Date submitted for ethics approval [1] 309130 0
06/07/2021
Approval date [1] 309130 0
25/08/2021
Ethics approval number [1] 309130 0

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

Contacts
Principal investigator
Name 113086 0
Dr Thushara Perera
Address 113086 0
Bionics Institute, 384-388 Albert Street, East Melbourne, VIC 3002
Country 113086 0
Australia
Phone 113086 0
+61 3 9667 7561
Fax 113086 0
Email 113086 0
tperera@bionicsinstitute.org
Contact person for public queries
Name 113087 0
Jo Crowston
Address 113087 0
Bionics Institute, 384-388 Albert Street, East Melbourne, VIC 3002
Country 113087 0
Australia
Phone 113087 0
+61 9667 7500
Fax 113087 0
Email 113087 0
jcrowston@bionicsinstitute.org
Contact person for scientific queries
Name 113088 0
Thushara Perera
Address 113088 0
Bionics Institute, 384-388 Albert Street, East Melbourne, VIC 3002
Country 113088 0
Australia
Phone 113088 0
+61 3 9667 7561
Fax 113088 0
Email 113088 0
tperera@bionicsinstitute.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data, including BiRD recordings and clinical assessment scores.
When will data be available (start and end dates)?
At the conclusion of the study. Data will be available for 5 years after publication.
Available to whom?
Research members who are affiliated and/or collaborators of the Bionics Institute.
Available for what types of analyses?
Future related ethically approved studies in Parkinson's disease.
How or where can data be obtained?
Contact principal investigator to discuss further via email, tperera@bionicsinstitute.org


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.