Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000359730
Ethics application status
Approved
Date submitted
27/03/2013
Date registered
5/04/2013
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Date results information initially provided
28/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating a targeted cognitive training program for the treatment of Freezing of Gait in Parkinson's Disease
Scientific title
Can targeted cognitive training alleviate symptoms of freezing of gait in patients with Parkinson's Disease?
Secondary ID [1] 281948 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Freezing of Gait in Parkinson's Disease 288362 0
Condition category
Condition code
Neurological 288710 288710 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will comprise of a 7-week targeted cognitive training program, aimed at improving aspects of cognition including attention, set-shifting, and processing speed in Parkinson's Disease (PD) patients suffering from freezing of gait (FOG). The program will involve two 2-hour sessions per week where patients will engage in computer-based cognitive training in addition to taking part in group-based discussion. This will be conducted in a specifically designed computer-based cognitive training laboratory, based at the Brain & Mind Research Centre.
Intervention code [1] 286511 0
Rehabilitation
Comparator / control treatment
An active control group will be employed, matched for time investment, computer-based activity and clinician/researcher and social interaction. This group will watch educational videos relating to topics such as nature, geography and science, and answer corresponding questionnaires, in addition to taking part in group-based discussions.
Control group
Active

Outcomes
Primary outcome [1] 288855 0
Blinded assessment of time spent frozen during Timed Up-and-Go (TUG) test. This will be assessed on two occasions. Firstly, while taking their usual PD medication regime, and secondly on a morning where they have not taken their PD medication.
Timepoint [1] 288855 0
Assessed within 3 weeks of final training session and compared with assessment within 3 weeks prior to the first training session
Secondary outcome [1] 301166 0
Investigation of the neural correlates of any training induced changes using functional MRI scans.
Timepoint [1] 301166 0
Assessed within 3 weeks of final training session and compared with assessment within 3 weeks prior to the first training session
Secondary outcome [2] 301168 0
Measurement of any improvement in psychosocial functioning as assessed through the following questionnaires: Parkinson's Disease Quality of Life Questionnaire (PDQ-39), Hospital Anxiety & Depression Scale (HADS), SCOPA-SLEEP Questionnaire, Thinking Skills Questionnaire and the Cambridge Behavioral Inventory Revised (CBI-R).
Timepoint [2] 301168 0
Assessed within 3 weeks of final training session and compared with assessment within 3 weeks prior to the first training session
Secondary outcome [3] 301392 0
Measurement of improved cognitive performance as assessed through the following tests: Montreal Cognitive Assessment (MOCA), Hopkins Verbal Learning Test Revised (HAVLT-R), Wechsler Adult Inteligence Scale (WAIS-III) - Digit Span subtest, Trail Making Test A & B, Delis-Kaplan Executive Function System (DKEFS) - Verbal Fluency & Symbol Digit Modalities (Oral) subtests, Cambridge Neuropsychological Test Automated Battery (CANTAB) - Affective Go/No Go & Reaction Time subtests, & Test of Everyday Attention (TEA) – Visual Elevator subtest
Timepoint [3] 301392 0
Assessed within 3 weeks of final training session and compared with assessment within 3 weeks prior to the first training session

Eligibility
Key inclusion criteria
This study will recruit 100 PD patients with a clinical history of FOG. We aim to recruit participants based on information obtained from medical assessments (including subjective report of symptoms and Mini Mental State Examination (MMSE) score of 24 or greater) as well as self-report measures of freezing (e.g. a positive score on question 3 of the FOG Questionnaire) completed at the PD Research Clinic located at the Brain and Mind Centre.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
MMSE of less than 24

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)
Participants will be approached via telephone based on previous medical and neuropsychological assessments at the PD Research Clinic to see if they are interested in taking part in the trial. Other participants may approach the clinic based on advertisement of the trial. Participants will then be sent out detailed information regarding the project in addition to consent forms. Participants will be allocated to groups using a blocked randomisation method conducted by a member of the clinical research team who is not in any way involved in the recruitment, assessment or training in the study. After baseline assessments, participants will receive a sealed envelope with a letter informing them about which group they have been allocated to. The envelopes are prepared by a person who is not involved in the assessment or training in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised at the time of the baseline assessment using a randomly generated number sequence allocated by a blinded researcher not involved in trial recruitment, data gathering, assessments or training. Randomisation will be undertaken using permuted blocks and stratified by cognitive functioning, with strata defined by MOCA scores of 'less than 26' or 'equal or greater than 26'
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
2/04/2013
Date of last participant enrolment
Anticipated
Actual
23/07/2015
Date of last data collection
Anticipated
Actual
7/10/2015
Sample size
Target
100
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286728 0
Charities/Societies/Foundations
Name [1] 286728 0
Michael J Fox Foundation
Country [1] 286728 0
United States of America
Primary sponsor type
Individual
Name
Professor Simon JG Lewis
Address
Brain & Mind Centre
100 Mallett Street,
Camperdown, 2050,
Sydney, New South Wales
Country
Australia
Secondary sponsor category [1] 285503 0
None
Name [1] 285503 0
Address [1] 285503 0
Country [1] 285503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288800 0
Human Ethics Committee, University of Sydney
Ethics committee address [1] 288800 0
Level 6
Jane Foss Russell Building G02
University of Sydney NSW 2006
Ethics committee country [1] 288800 0
Australia
Date submitted for ethics approval [1] 288800 0
Approval date [1] 288800 0
13/01/2013
Ethics approval number [1] 288800 0
Protocol No. 2012/2915

Summary
Brief summary
We will evaluate whether a course of cognitive training can reduce symptoms of FOG in PD. This study will randomize patients into either a 7-week program of cognitive training or a sham control condition. Treatment response will be assessed by video recordings of specific walking tasks (TUG), taken before and after training. In addition, functional brain imaging whilst patients perform a validated virtual reality gait paradigm will be used to determine the brain activation patterns associated with improvements in FOG.

This project will hopefully identify an effective novel treatment for FOG that does not involve pharmacological or surgical intervention. The use of brain imaging will also allow us to see why patients might have differential responses to therapy. Identifying the nature of these relationships will hopefully advance our understanding of freezing and lead to new directions for targeting therapy.
Trial website
http://sydney.edu.au/bmri/research/mental-health-clinical/ageing-brain.php#parkinsons
Trial related presentations / publications
Lewis, S. J. G. & Barker, R. A. (2009). A pathophysiological model of freezing of gait in Parkinson's disease. Parkinsonism and Related Disorders, 15(5), 333-8

Naismith, S. L., Shine, J. M. & Lewis, S. J. (2010). The specific contributions of set-shifting to freezing of gait in Parkinson's disease. Movement Disorders, 25(8), 1000-4

Shine, J. M., Naismith, S. L. & Lewis, S. J. (2012). The differential yet concurrent contributions of motor, cognitive and affective disturbance to freezing of gait in Parkinson's disease. Clinical Neurology and Neurosurgery: In Press

Shine, J. M., Ward, P. B., Naismith, S. L., Pearson, M. & Lewis, S. J. G. (2011). Utilising functional MRI (fMRI) to explore the freezing phenomenon in Parkinson's disease. Journal of Clinical Neuroscience, 18(6), 807-10

Naismith, S. L., Mowszowski, L., Diamond, K. & Lewis, S. J. G. (In Press). Improved memory in Parkinson's Disease: A healthy brain ageing cognitive training program. Movement Disorders.
Public notes

Contacts
Principal investigator
Name 37826 0
Prof Simon Lewis
Address 37826 0
Brain & Mind Centre
100 Mallett Street,
Camperdown, 2050,
Sydney, New South Wales
Country 37826 0
Australia
Phone 37826 0
+61 2 9351 0702
Fax 37826 0
Email 37826 0
[email protected]
Contact person for public queries
Name 37827 0
Prof Simon Lewis
Address 37827 0
Brain & Mind Centre
100 Mallett Street,
Camperdown, 2050,
Sydney, New South Wales
Country 37827 0
Australia
Phone 37827 0
+61 2 9351 0702
Fax 37827 0
Email 37827 0
[email protected]
Contact person for scientific queries
Name 37828 0
Prof Simon Lewis
Address 37828 0
Brain & Mind Centre
100 Mallett Street,
Camperdown, 2050,
Sydney, New South Wales
Country 37828 0
Australia
Phone 37828 0
+61 2 9351 0702
Fax 37828 0
Email 37828 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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCognitive training for freezing of gait in Parkinson's disease: a randomized controlled trial.2018https://dx.doi.org/10.1038/s41531-018-0052-6
N.B. These documents automatically identified may not have been verified by the study sponsor.