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Trial registered on ANZCTR
Registration number
ACTRN12619001196134
Ethics application status
Approved
Date submitted
19/07/2019
Date registered
27/08/2019
Date last updated
27/08/2019
Date data sharing statement initially provided
27/08/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Magnetic brain stimulation for multiple sclerosis trial
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Scientific title
Phase 1/2 study examining the safety of transcranial magnetic stimulation in people with multiple sclerosis
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Secondary ID [1]
298790
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis
313742
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Condition category
Condition code
Neurological
312143
312143
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0
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Multiple sclerosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Low intensity 10Hz theta burst transcranial magnetic stimulation or sham stimulation over the frontal head region for 6 minutes at a time for 20 sessions (one per week day) over 4 weeks. The same site will be used for each stimulation/sham stimulation using biometric landmarks recorded for all participants at the first study visit.This will be administered by trained research staff (PhD student and medical student) under the supervision of a TMS expert and direct medical supervision whilst in the clinic setting. Random administrations will be observed by the supervising neurologist and also the TMS expert(psychologist). A trained and registered medical practitioner will be on site. All stimulations will be undertaken in the clinical research facility at the Menzies Institute for medical research, medical sciences precinct University of Tasmania.
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Intervention code [1]
315060
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Treatment: Devices
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Comparator / control treatment
Placebo sham stimulation provided as a program in the TMS machine that makes the same sound as the TMS but without delivering the magnetic stimulation. Participants cannot tell the difference between actual stimulation and sham
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Control group
Placebo
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Outcomes
Primary outcome [1]
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safety and tolerability of TMS in people with multiple sclerosis .Low intensity TMS is associated with very few if any side effects. It is well tolerated however participants can report mild headache and a feeling of mild disorientation usually transient. In rare circumstances seizure activity can occur. This is mitigated by exclusion of those at risk of seizures, All side effects will be recorded in the study by a study specific questionnaire at the end of each session and before the start of the next session. At the end of the study the participants will be asked at their exit visit about any side effects and also whether they thought they were in the active or sham groups.
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Assessment method [1]
320791
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Timepoint [1]
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6 weeks post baseline visit
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Secondary outcome [1]
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Change in MRI remyelination measures between baseline and week 6 weeks of study.
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Assessment method [1]
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Timepoint [1]
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6 weeks after baseline visit
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Secondary outcome [2]
373715
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Change in depression as measured by change in the HADS depression score at 6 weeks compared to baseline.
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Assessment method [2]
373715
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Timepoint [2]
373715
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6 weeks post baseline visit
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Secondary outcome [3]
373716
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Change in cognition as measured by MS reactor at 6 weeks compared to baseline.
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Assessment method [3]
373716
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Timepoint [3]
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6 weeks post baseline visit
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Eligibility
Key inclusion criteria
Definite MS aged 18-65. either secondary progressive or relapsing remitting MS.
Able to have an MRI scan.
EDSS < /= to 6.
At least moderate cerebral MS plaque load as determined by trial neurologist.
Able to give informed consent .
Not pregnant.
Not on anti epileptic and antipsychotic medications.
No metallic devices or foreign bodies
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Other types of MS
Pregnancy .
Unable to have an MRI scan.
unable to provide consent.
On antiepileptic or antipsychotic medications.
History of other concomitant neurological disorder that may complicate assessment e.g. Parkinson's Epilepsy Migraine or Stroke.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
T tests for parametric data
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/09/2019
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Actual
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Date of last participant enrolment
Anticipated
4/11/2019
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Actual
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Date of last data collection
Anticipated
20/12/2019
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
TAS
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Funding & Sponsors
Funding source category [1]
303348
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Charities/Societies/Foundations
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Name [1]
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Multiple Sclerosis Research Australia
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Address [1]
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PO Box 625, North Sydney NSW 2059
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Tasmania
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Address
Medical Science Precinct 17 Liverpool Street Hobart TAS 7000
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Country
Australia
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Secondary sponsor category [1]
303378
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None
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Name [1]
303378
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Address [1]
303378
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Country [1]
303378
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Tasmanian Health and Medical research Committee
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Ethics committee address [1]
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Tasmanian Health and Medical research Committee University of Tasmania Private Bag 1 Sandy Bay Tasmania 7005
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
303878
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Approval date [1]
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12/06/2019
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Ethics approval number [1]
303878
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H001789
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Summary
Brief summary
Transcranial magnetic stimulation is a safe and well proven technique used to treat a number of psychiatric and neurological disorders. It has never been trialled in MS. We have demonstrated that TMS may have an effect on the ability of brain cells to replenish the myelin sheath (the insulation surrounding nerve cells) which may thus help multiple sclerosis lesions to heal. This data is from animals and cell culture and has not been shown in humans. This study is a safety/tolerability study of TMS in humans to determine whether wee can give TMS to people with MS with acceptable tolerability and safety. We will also collect preliminary data on the effects of TMS on people with MS and their MRI scans
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Trial website
Not yet established
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Trial related presentations / publications
Nil
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Public notes
Nil
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Contacts
Principal investigator
Name
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Prof Bruce Taylor
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Address
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Menzies Institute for Medical Research
University of Tasmania
Medical Sciences
Liverpool Street
Hobart
Tas 7000
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Country
95098
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Australia
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Phone
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+61 03 62267700
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Fax
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Email
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bruce.taylor@utas.edu.au
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Contact person for public queries
Name
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Prof Bruce Taylor
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Address
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Menzies Institute for Medical Research
University of Tasmania
Medical Sciences
Liverpool Street
Hobart
Tas 7000
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Country
95099
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Australia
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Phone
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+61 03 62267700
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Fax
95099
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Email
95099
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bruce.taylor@utas.edu.au
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Contact person for scientific queries
Name
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Prof Bruce Taylor
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Address
95100
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Menzies Institute for Medical Research
University of Tasmania
Medical Sciences
Liverpool Street
Hobart
Tas 7000
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Country
95100
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Australia
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Phone
95100
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+61 03 62267700
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Fax
95100
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Email
95100
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bruce.taylor@utas.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Due to small sample size and small local community we cannot guarantee privacy if individual level data is released
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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
Transcranial magnetic stimulation (TMS) and repetitive TMS in multiple sclerosis.
2021
https://dx.doi.org/10.1515/revneuro-2020-0140
Embase
Safety of low-intensity repetitive transcranial magneTic brAin stimUlation foR people living with mUltiple Sclerosis (TAURUS): study protocol for a randomised controlled trial.
2022
https://dx.doi.org/10.1186/s13063-022-06526-z
Dimensions AI
A little goes a long way: Neurobiological effects of low intensity rTMS and implications for mechanisms of rTMS
2022
https://doi.org/10.1016/j.crneur.2022.100033
N.B. These documents automatically identified may not have been verified by the study sponsor.
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