Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000119897
Ethics application status
Approved
Date submitted
4/01/2012
Date registered
24/01/2012
Date last updated
2/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy diagnosis: a longitudinal study.
Scientific title
Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy diagnosis: a longitudinal study.
Secondary ID [1] 279650 0
nil
Universal Trial Number (UTN)
U1111-1126-7750
Trial acronym
TIPSY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PROGRESSIVE SUPRANUCLEAR PALSY 285455 0
MULTIPLE SYSTEM ATROPHY 285456 0
PARKINSON'S DISEASE 285457 0
Condition category
Condition code
Neurological 285640 285640 0 0
Neurodegenerative diseases
Neurological 285641 285641 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Transcranial Magnetic Stimulation (TMS)
TMS will be performed on each participant at each 6 month reveiw period. This will include 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 each session, and will be conducted on 5 occasions for each participant, separated by 6 months each time, for a total study duration of 2 years.
Intervention code [1] 283936 0
Not applicable
Comparator / control treatment
All participants will have Transcranial Magnetic Stimulation. Participants will be recruited in 4 groups, thus: Progressive supranuclear Palsy; Multiple System Atrophy; Parkinson's Disease; and Normal controls without neurological disease. Inclusion criteria for each group will be absed on published clinical diagnostic criteria. Comparisons between the included groups will be conducted of short interval cortical inhibition and motor evoked potential resposes to theta burst stimulation between patients in different diagnostic entities.
Control group
Active

Outcomes
Primary outcome [1] 286197 0
1. Do measured responses in short interval cortical inhibition to theta burst stimulation correlate with clinical features as measured by physical and cognitive rating scales in Progressive Supranuclear Palsy.
Timepoint [1] 286197 0
Measured 6 monthly for 2 years
Secondary outcome [1] 295365 0
2. Do Transcranial Magnetic Stimulation parameters distinguish between parkinsonian syndromes, ie. Progressive Supranuclear Palsy, Multiple System Atrophy and Parkinson's Disease.
Timepoint [1] 295365 0
Measured 6 monthly for 2 years

Eligibility
Key inclusion criteria
Four groups to be recruited:
1. 20 People with Progressive Supranuclear Palsy as defined by National Institute of Neurological Diseases and Stroke criteria
2. 10 People with "probable" or "possible" Multiple System Atrophy according to published consensus criteria
3. 10 People with Parkinson's Disease according to Queens Square Brain Bank criteria
4. 10 normal controls
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.People with epilepsy
2.People with intracranial metal whith 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 at baseline
4. Patients deemed not cabable 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
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/01/2012
Actual
3/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284441 0
University
Name [1] 284441 0
Monash University
Country [1] 284441 0
Australia
Primary sponsor type
Individual
Name
A/Prof David Williams
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] 283364 0
Hospital
Name [1] 283364 0
Alfred Hospital
Address [1] 283364 0
Neurosciences
Alfred Hospital
Commercial road
Melbourne
Victoria 3000
Country [1] 283364 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286407 0
THE ALFRED HUMAN ETHICS COMMITTEE
Ethics committee address [1] 286407 0
ALFRED HOSPITAL
COMMERCIAL ROAD
MELBOURNE
Victoria 3000
Ethics committee country [1] 286407 0
Australia
Date submitted for ethics approval [1] 286407 0
19/09/2011
Approval date [1] 286407 0
23/09/2011
Ethics approval number [1] 286407 0
1/11/0342

Summary
Brief summary
Progressive Supranuclear Palsy (PSP) is an idiopathic, rapidly progressive neurodegenerative disease for which there is currently no diagnostic test or any disease modifying treatment. It is caused by an accumulation of mictotubule associated tau protein in the basal ganglia, midbrain and cortical regions. There is selective loss of inhibitory interneurones and corticocortical projections leading to frontal atrophy which may correlate with the motor and cognitive disabilities. Transcranial Magnetic Stimulation is capable of inducing action potentials in cortical neurones, and provides the capacity to measure cortical neuronal excitabilityand interneuronal function. Preliminary data shows this may be a method for measuring neuronal function in PSP, which may enable its use as a biomarker. The intention of this study is to determine if these measure ments are able to distinguish PSP from other parkinsonian syndromes with similar clinical features, and if these measurements correlate with advancing clinical features over time.
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 paimary motor cortex in patients with Progressive Supranuclear Palsy. (abstract) International Congress of Parkinson's disease and other movement disorders, June 2013
Public notes

Contacts
Principal investigator
Name 33569 0
A/Prof David Williams
Address 33569 0
Van Cleef Roet Centre for Neurosciences
Level 4, central block
Alfred Hospital
Commercial Road
Melbourne
Victoria 3000
Country 33569 0
Australia
Phone 33569 0
+ 61 3 9076 2000
Fax 33569 0
Email 33569 0
david.williams@monash.edu.au
Contact person for public queries
Name 16816 0
Dr DR KELLY BERTRAM
Address 16816 0
Neurosciences
Level 4 Central block
Alfred Hospital
Commercial Road
Melbourne
Victoria 3000
Country 16816 0
Australia
Phone 16816 0
+61 3 9076 2000
Fax 16816 0
+61 3 9076 2671
Email 16816 0
k.bertram@alfred.org.au
Contact person for scientific queries
Name 7744 0
Dr DR KELLY BERTRAM
Address 7744 0
Neurosciences
Level 4 Central block
Alfred Hospital
Commercial Road
Melbourne
Victoria 3000
Country 7744 0
Australia
Phone 7744 0
+61 3 9076 2000
Fax 7744 0
+ 61 3 9076 2671
Email 7744 0
k.bertram@alfred.org.au

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Results publications and other study-related documents

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