Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000934347
Ethics application status
Approved
Date submitted
1/06/2017
Date registered
28/06/2017
Date last updated
28/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transcranial Magnetic Stimulation in the diagnosis of Atypical Parkinsonism
Scientific title
Transcranial Magnetic Stimulation in the diagnosis of Atypical Parkinsonism
Secondary ID [1] 292108 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record
U1111-1126-7750

Health condition
Health condition(s) or problem(s) studied:
PROGRESSIVE SUPRANUCLEAR PALSY 303527 0
MULTIPLE SYSTEM ATROPHY 303528 0
PARKINSON'S DISEASE 303529 0
Condition category
Condition code
Neurological 302939 302939 0 0
Parkinson's disease
Neurological 302951 302951 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Transcranial Magnetic Stimulation (TMS)
TMS will be performed on each participant including measures of
intracortical inhibition and facilitation, resting motor thresholds and motor evoked potentials before and after theta burst stimulation. The TMS protocol is expected to take 2-3 hours. In addition each participant will undergo standardised cognitive tests.
Intervention code [1] 298254 0
Not applicable
Comparator / control treatment
comparator is between disease entities and with normal control subjects, all participants will undergo the same examination and testing protocol.
Control group
Active

Outcomes
Primary outcome [1] 302338 0
Short interval cortical inhibition as measured by Transcranial Magnetic Stimulation
Timepoint [1] 302338 0
single visit for each participant
Primary outcome [2] 302540 0
Excitability response to theta burst transcranial magnetic stimulation
Timepoint [2] 302540 0
single visit for all participants
Secondary outcome [1] 335560 0
Cognitive changes as measured by Addenbrookes cognitive assessment(ACE-r)
Timepoint [1] 335560 0
single visit per participant
Secondary outcome [2] 336342 0
Cognitive assessment as measured by Frontal Assessment Battery (FAB)
Timepoint [2] 336342 0
single visit for each participant

Eligibility
Key inclusion criteria
Four groups to be recruited:
1. 10 People with Progressive Supranuclear Palsy as defined by National Institute of Neurological Diseases and Stroke criteria
2. 15 People with "probable" or "possible" Multiple System Atrophy according to published consensus criteria (Golbe criteria)
3. 15 People with Parkinson's Disease according to Queens Square Brain Bank criteria
4. 20 normal controls over 40 years of age without symptoms of neurodegenerative brain disease or parkinsonism
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.People with epilepsy
2.People with intracranial metal which may increase the risk of seizures or injury due to Transcranial Magnetic Stimulation
3. People not able to complete clinical rating scales including cognitive assessment
4. Patients deemed not capable of consenting to involvement in the study and for whom an appropriate
person responsible is not available to participate in the consenting process

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
between groups analysis of TMS measurements will be conducted, and correlation analysis between TMS recordings and cognitive assessment rating scales.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/07/2016
Date of last participant enrolment
Anticipated
29/12/2017
Actual
Date of last data collection
Anticipated
29/12/2017
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8238 0
The Alfred - Prahran
Recruitment postcode(s) [1] 16296 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 296641 0
Charities/Societies/Foundations
Name [1] 296641 0
Parkinson's Victoria
Country [1] 296641 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Van Cleef Roet Centre for Nervous Diseases
Monash University
Level 4 Central Block
Commercial Road
Alfred Hospital
Melbourne
Victoria 3000
Country
Australia
Secondary sponsor category [1] 295600 0
None
Name [1] 295600 0
Address [1] 295600 0
Country [1] 295600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297870 0
THE ALFRED HUMAN ETHICS COMMITTEE
Ethics committee address [1] 297870 0
ALFRED HOSPITAL
COMMERCIAL ROAD
MELBOURNE
Victoria 3000
Ethics committee country [1] 297870 0
Australia
Date submitted for ethics approval [1] 297870 0
18/02/2016
Approval date [1] 297870 0
29/04/2016
Ethics approval number [1] 297870 0
118/16

Summary
Brief summary
Transcranial Magnetic Stimulation is capable of inducing action potentials in cortical neurones, and provides the capacity to measure cortical neuronal excitability and interneuronal function. Preliminary data in previous studies shows this may be a method for measuring neuronal function in Progressive Supranuclear Palsy, which may enable its use as a biomarker. The intention of this study
is to determine if these measurements are able to distinguish PSP from other parkinsonian syndromes with similar clinical features,
ie. Multiple System Atrophy and Parkinson's Disease, and if these measurements correlate with markers of disease activity including cognitive changes. Results will also be compared with a group of healthy control participants to determine the reliability of these measurements.
Trial website
Trial related presentations / publications
1. Conte, C. Belvisi, D. Bologna, M. Ottaviani, D. Fabbrini, G. Colosimo, C. Williams, DR. Berardelli, A. Abnormal cortical synaptic plasticity in primary motor area in progressive supranuclear palsy. Cerebral Cortex 2011:jun 15
2. Bologna, M. Bertram, K. Conte, A. Scott, K. Williams, DR. Berardelli, A. Reversal of long term potentiation-like plasticity in primary motor cortex in patients with Progressive Supranuclear Palsy. (abstract)
Public notes

Contacts
Principal investigator
Name 75326 0
A/Prof David Williams
Address 75326 0
Van Cleef Roet Centre for Neurosciences
Monash university
Level 4, central block
Alfred Hospital
Commercial Road
Melbourne
Victoria 3000
Country 75326 0
Australia
Phone 75326 0
+ 61 3 9076 2059
Fax 75326 0
+61 3 9076 2671
Email 75326 0
david.williams@monash.edu.au
Contact person for public queries
Name 75327 0
Dr Kelly Bertram
Address 75327 0
Van Cleef Roet Centre for Neurosciences
Monash university
Level 4, central block
Alfred Hospital
Commercial Road
Melbourne
Victoria 3000
Country 75327 0
Australia
Phone 75327 0
+ 61 3 9076 2059
Fax 75327 0
+61 3 9076 2671
Email 75327 0
k.bertram@alfred.org.au
Contact person for scientific queries
Name 75328 0
Dr Kelly Bertram
Address 75328 0
Van Cleef Roet Centre for Neurosciences
Monash University
Level 4, central block
Alfred Hospital
Commercial Road
Melbourne
Victoria 3000
Country 75328 0
Australia
Phone 75328 0
+ 61 3 9076 2059
Fax 75328 0
+61 3 9076 2671
Email 75328 0
k.bertram@alfred.org.au

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
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