Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000944235
Ethics application status
Approved
Date submitted
9/05/2018
Date registered
5/06/2018
Date last updated
5/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Postural stability after deep brain stimulation in Parkinson disease patients
Scientific title
Optimizing the post-operative management of Parkinson disease patients with deep brain stimulation
Secondary ID [1] 294744 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 307633 0
Postural instability 307636 0
Condition category
Condition code
Neurological 306701 306701 0 0
Parkinson's disease
Musculoskeletal 306847 306847 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 Patients who have previously undergone bilateral deep brain stimulation surgery that has targeted the subthalamic nuclei (DBS-STN) and who agree to participate will be invited to complete two testing sessions conducted on non-consecutive days of no more than 2-weeks apart at the Asia-Pacific Centre for Neuromodulation in Brisbane. Patients will be asked to withdraw from any pharmacological treatments (i.e. treatment that is supplementary to DBS-STN) 12 hours prior to (i.e. overnight) each of these sessions to negate the effects of these therapies and facilitate the exclusive evaluation of the DBS-STN therapy. The adherence to the withdraw will be confirmed via questionnaires on the day of testing. During each testing session, patients will be assessed under two therapeutic conditions, details of which are outlined below, and data collection for each condition is expected to take between 2 and 3 hours (including rest breaks). Specifically, the DBS-STN conditions to be examined will include:

Day 1, Condition 1: DBS-STN electrodes bilaterally active (ON) with clinically-recommended settings. Clinically-recommended settings determined by usual programming procedures (e.g. =130Hz, 2-4 Volts, 60us).
Day 1, Condition 2: DBS-STN electrodes bilaterally set to low frequency (60Hz) with an adjusted voltage to maintain the total electrical energy derived with clinically-recommended settings.

Day 2, Condition 1: DBS-STN electrodes bilaterally active (ON) with clinically-recommended settings. Clinically-recommended settings determined by usual programming procedures (e.g. =130Hz, 2-4 Volts, 60us).
Day 2, Condition 2: DBS-STN electrodes bilaterally inactive (OFF)

The order of therapeutic conditions within each day will be assessed in a randomized order and all patients will be assessed under each condition. There will be a one-hour wash in period after change of stimulation before assessment takes place. The interventions (setting changes) will be performed by a registered nurse who specialises in the post-operative management of DBS-STN patients
Intervention code [1] 301046 0
Treatment: Devices
Comparator / control treatment
The control condition of this study will be the conditions with the DBS-STN electrodes bilaterally programmed to their clinically-recommended settings. Therefore the control treatment is standard care with patients acting as their own control.
Control group
Active

Outcomes
Primary outcome [1] 305705 0
Walking rhythmicity: Will be assessed using data derived from head- and trunk-worn accelerometers (3D), which will be used to calculate harmonic ratios. The harmonic ratio of accelerometry data provides insight into the symmetry/rhythmicity of the acceleration signals, with more rhythmic patterns suggested to represent better gait stability.
Timepoint [1] 305705 0
1 hour following the intervention (DBS-STN condition)
Primary outcome [2] 305706 0
Muscle function as measured by surface electromyography: To evaluate muscle activation, the reported muscle activations will be the average normalised activation of the thoracic erector spinae and lumbar multifidus over the duration of the stance phase. Additionally, measures of muscle function will include the peak and baseline measures of muscle activation during gait.
Timepoint [2] 305706 0
1 hour following the intervention (DBS-STN condition)
Primary outcome [3] 305818 0
Standing balance: Will be assessed while during quiet stance for 30 seconds as well as during a limits of stability task performed on an force plate. The composite measure for balance will be derived from the force plate data will include the range and standard deviations of the center of pressure displacements, the total sway area and the sway velocity.
Timepoint [3] 305818 0
1 hour following the intervention (DBS-STN condition)
Secondary outcome [1] 346208 0
Unified Parkinson’s Disease Rating Scale (UPDRS) total score to provide an insight into symptom severity.
Timepoint [1] 346208 0
1 hour following the intervention (DBS-STN condition)

Eligibility
Key inclusion criteria
Individuals clinically-diagnosed with idiopathic PD who have undergone DBS-STN no less than 12-months previous to the day of testing.
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they; 1) have had recent surgery or have a history of recurrent musculoskeletal injury; 2) are unable to walk without assistance; or 3) have significant cognitive impairment (Standardized Mini Mental State Examination <25).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Individuals who consent to participate in this study will be asked to attend two non-consecutive days at the Asia-Pacific Centre for Neuromodulation in Brisbane. The order of the therapeutic conditions for each respective day of testing will be randomized. The randomisation process will be completed by a member of the research team who will have no direct involvement in the recruitment or assessment of the research participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of therapeutic conditions within each day for each participant will be determined using a random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model analyses will be used to examine differences between conditions for the outcome measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/06/2018
Actual
Date of last participant enrolment
Anticipated
1/12/2018
Actual
Date of last data collection
Anticipated
17/12/2018
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 22607 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 299350 0
University
Name [1] 299350 0
Australian Catholic University
Country [1] 299350 0
Australia
Funding source category [2] 299431 0
Government body
Name [2] 299431 0
Research Training Program
Country [2] 299431 0
Australia
Primary sponsor type
Individual
Name
Dr. Michael Cole
Address
Australian Catholic University
PO Box 456
Virginia QLD, 4014
Country
Australia
Secondary sponsor category [1] 298625 0
Individual
Name [1] 298625 0
Zachary Conway
Address [1] 298625 0
Australian Catholic University
PO Box 456
Virginia QLD, 4014
Country [1] 298625 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300255 0
The Australian Catholic Univeristy Human Research Ethics Committee
Ethics committee address [1] 300255 0
Ethics committee country [1] 300255 0
Australia
Date submitted for ethics approval [1] 300255 0
Approval date [1] 300255 0
25/08/2017
Ethics approval number [1] 300255 0
2017-155H

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

Contacts
Principal investigator
Name 83066 0
Dr Michael Cole
Address 83066 0
Australian Catholic University
PO Box 456
Virginia Queensland 4014
Country 83066 0
Australia
Phone 83066 0
+61 7 36237674
Fax 83066 0
Email 83066 0
[email protected]
Contact person for public queries
Name 83067 0
Zachary Conway
Address 83067 0
Australian Catholic University
PO Box 456
Virginia Queensland 4014
Country 83067 0
Australia
Phone 83067 0
+61 7 36237385
Fax 83067 0
Email 83067 0
[email protected]
Contact person for scientific queries
Name 83068 0
Zachary Conway
Address 83068 0
Australian Catholic University
PO Box 456
Virginia Queensland 4014
Country 83068 0
Australia
Phone 83068 0
+61 7 36237385
Fax 83068 0
Email 83068 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseLow-frequency STN-DBS provides acute gait improvements in Parkinson's disease: a double-blinded randomised cross-over feasibility trial.2021https://dx.doi.org/10.1186/s12984-021-00921-4
N.B. These documents automatically identified may not have been verified by the study sponsor.