ANZCTR - Registration

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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 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]

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

Condition category

Condition code

Neurological

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]

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]

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]

Assessed within 3 weeks of final training session and compared with assessment within 3 weeks prior to the first training session

Secondary outcome [1]

Investigation of the neural correlates of any training induced changes using functional MRI scans.

Timepoint [1]

Assessed within 3 weeks of final training session and compared with assessment within 3 weeks prior to the first training session

Secondary outcome [2]

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]

Assessed within 3 weeks of final training session and compared with assessment within 3 weeks prior to the first training session

Secondary outcome [3]

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]

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?

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

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Michael J Fox Foundation

Address [1]

The Michael J. Fox Foundation for Parkinson's Research
Grand Central Station
P.O. Box 4777
New York, NY 10163-4777

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Ethics Committee, University of Sydney

Ethics committee address [1]

Level 6 
Jane Foss Russell Building G02
University of Sydney NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/01/2013

Ethics approval number [1]

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

Prof Simon Lewis

Address

Brain & Mind Centre
100 Mallett Street,
Camperdown, 2050,
Sydney, New South Wales

Country

Australia

Phone

+61 2 9351 0702

Fax

simon.lewis@sydney.edu.au

Contact person for public queries

Name

Simon Lewis

Address

Brain & Mind Centre
100 Mallett Street,
Camperdown, 2050,
Sydney, New South Wales

Country

Australia

Phone

+61 2 9351 0702

Fax

simon.lewis@sydney.edu.au

Contact person for scientific queries

Name

Simon Lewis

Address

Brain & Mind Centre
100 Mallett Street,
Camperdown, 2050,
Sydney, New South Wales

Country

Australia

Phone

+61 2 9351 0702

Fax

simon.lewis@sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Cognitive training for freezing of gait in Parkinson's disease: a randomized controlled trial.	2018	https://dx.doi.org/10.1038/s41531-018-0052-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

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