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Trial registered on ANZCTR


Registration number
ACTRN12609000393257
Ethics application status
Approved
Date submitted
10/05/2009
Date registered
1/06/2009
Date last updated
25/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of repetitive transcranial magnetic stimulation protocols in healthy volunteers for use in neurological disorders.
Scientific title
The effects of frequency and amplitude of low frequency repetitive transcranial magnetic stimulation of the motor cortex on motor evoked potentials, simple motor reaction times and strength in healthy human volunteers: a study to improve magnetic brain stimulation as a treatment for neurological disorders, especially stroke.
Secondary ID [1] 288415 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurological conditions, especially stroke 4709 0
Condition category
Condition code
Stroke 237238 237238 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Repetitive transcranial magnetic stimulation (rTMS) will be performed with a Magstim Rapid2 stimulator using a 70 mm figure of 8 coil over the right motor cortex and will involve stimulation at frequencies of 1, 0.2 or 0.05 Hz and at amplitude of 80% or 110% of resting motor threshold (RMT) lasting 10 minutes.
Intervention code [1] 236680 0
Treatment: Devices
Comparator / control treatment
Repetitive Transcranial Magnetic Stimulation (rTMS) will be used at 3 frequencies (1, 0.2 and 0.05 Hz) and two amplitudes (Low - 80% of RMT and High - 110% of RMT.
There will be a cross over design with at least one week between treatments.

Arm 1: rTMS at 1 hz and amplitude 80% RMT
Arm 2. rTMS at 1 Hz and amplitude 110% RMT
Arm 3. rTMS at 0.2 Hz and amplitude 80% RMT
Arm 4. rTMS at 0.2 Hz and amplitude 110% RMT
Arm 5. rTMS at 0.05 Hz and amplitude 80% RMT
Arm 6. rTMS at 0.05 Hz and amplitude 110% RMT
Control group
Dose comparison

Outcomes
Primary outcome [1] 5866 0
Simple motor reaction times; based on pressing a key on a computer keyboard in response to a visual stimulus (green circle), using ePrime software.
Timepoint [1] 5866 0
Immediately after rTMS, 30 minutes post TMS
Primary outcome [2] 5867 0
Motor evoked potential amplitude using Magstim Rapid2 stimulator at 110% RMT and recording with surface electrodes over the left first dorsal interosseus muscle.
Timepoint [2] 5867 0
Immediately following rTMS
Primary outcome [3] 5868 0
Cortical silent period, measured as for motor evoked potential amplitude, with participant contracting the first dorsal interosseus at 15% of peak voluntary contraction.
Timepoint [3] 5868 0
Immediately following rTMS
Secondary outcome [1] 241897 0
Strength: peak contraction as recorded on handgrip and pinchgrip manometers
Timepoint [1] 241897 0
Immediately after rTMS, 30 minutes post rTMS

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Neurological disease
Epilepsy

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)
Healthy volunteers will be recruited and each will receive 4 out of 6 possible combinations of TMS amplitude and frequency.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Williams design
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/05/2009
Actual
13/05/2009
Date of last participant enrolment
Anticipated
30/06/2010
Actual
16/10/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 1746 0
New Zealand
State/province [1] 1746 0
Otago

Funding & Sponsors
Funding source category [1] 4926 0
Charities/Societies/Foundations
Name [1] 4926 0
Healthcare Otago Charitable Trust
Country [1] 4926 0
New Zealand
Primary sponsor type
Individual
Name
Graeme Hammond-Tooke
Address
Department of Medical and Surgical Sciences
University of Otago
PO Box 913
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 4455 0
University
Name [1] 4455 0
University of Otago
Address [1] 4455 0
PO Box 913
Dunedin 9054
Country [1] 4455 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6999 0
Lower South Regional Ethics Committee
Ethics committee address [1] 6999 0
P O Box 5849
Dunedin 9054
Ethics committee country [1] 6999 0
New Zealand
Date submitted for ethics approval [1] 6999 0
Approval date [1] 6999 0
16/04/2009
Ethics approval number [1] 6999 0
LRS/09/03/006

Summary
Brief summary
Healthy volunteers will be treated with 10 minutes of repetitive transcranial magnetic stimulation of the motor cortex using 3 different (low) frequencies and 2 different amplitudes. Simple motor reaction times and motor evoked potentials will be studied immediately before and after, and after 30 minutes. The aim is to ascertain the optimal protocol for modifying the excitability of the motor cortex in neurological disorders.
Trial website
Trial related presentations / publications
The study has not been published. in full.
Some of the data was presented at 29th International Congress of Clinical Neurophysiology, Kobe, Japan, November 2010:
G.D. Hammond-Tooke, J. Heaton, F. Tallabs Grajeda, K. Endo, P. Herbison, E.A. Franz. Modification of ipsilateral reaction times by 1Hz repetitive transcranial magnetic stimulation of the motor cortex. Clinical Neurophysiology, Volume 121, Supplement 1, October 2010, Page S224. P20-20.
Public notes

Contacts
Principal investigator
Name 29560 0
A/Prof Graeme Hammond-Tooke
Address 29560 0
Department of Medicine
University of Otago
PO Box 516
Dunedin 9054
New Zealand
Country 29560 0
New Zealand
Phone 29560 0
64 3 474099
Fax 29560 0
Email 29560 0
graeme.hammond-tooke@southerndhb.govt.nz
Contact person for public queries
Name 12807 0
A/Prof Graeme Hammond-Tooke
Address 12807 0
Department of Medicine
University of Otago
PO Box 516
Dunedin 9054
New Zealand
Country 12807 0
New Zealand
Phone 12807 0
64 3 474 0999
Fax 12807 0
64 3 4709656
Email 12807 0
graemeH@healthotago.co.nz
Contact person for scientific queries
Name 3735 0
A/Prof Graeme Hammond-Tooke
Address 3735 0
Department of Medicine
University of Otago
PO Box 516
Dunedin 9054
New Zealand
Country 3735 0
New Zealand
Phone 3735 0
64 3 474 0999
Fax 3735 0
64 3 4709656
Email 3735 0
graemeH@healthotago.co.nz

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

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