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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
Scientific title
Phase 1/2 study examining the safety of transcranial magnetic stimulation in people with multiple sclerosis
Secondary ID [1] 298790 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis 313742 0
Condition category
Condition code
Neurological 312143 312143 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 315060 0
Treatment: Devices
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
Control group
Placebo

Outcomes
Primary outcome [1] 320791 0
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.
Timepoint [1] 320791 0
6 weeks post baseline visit
Secondary outcome [1] 372863 0
Change in MRI remyelination measures between baseline and week 6 weeks of study.
Timepoint [1] 372863 0
6 weeks after baseline visit
Secondary outcome [2] 373715 0
Change in depression as measured by change in the HADS depression score at 6 weeks compared to baseline.
Timepoint [2] 373715 0
6 weeks post baseline visit
Secondary outcome [3] 373716 0
Change in cognition as measured by MS reactor at 6 weeks compared to baseline.
Timepoint [3] 373716 0
6 weeks post baseline visit

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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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)
Sealed opaque envelopes
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)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
T tests for parametric data

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 303348 0
Charities/Societies/Foundations
Name [1] 303348 0
Multiple Sclerosis Research Australia
Address [1] 303348 0
PO Box 625, North Sydney NSW 2059
Country [1] 303348 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Medical Science Precinct 17 Liverpool Street Hobart TAS 7000
Country
Australia
Secondary sponsor category [1] 303378 0
None
Name [1] 303378 0
Address [1] 303378 0
Country [1] 303378 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303878 0
Tasmanian Health and Medical research Committee
Ethics committee address [1] 303878 0
Tasmanian Health and Medical research Committee University of Tasmania Private Bag 1 Sandy Bay Tasmania 7005
Ethics committee country [1] 303878 0
Australia
Date submitted for ethics approval [1] 303878 0
Approval date [1] 303878 0
12/06/2019
Ethics approval number [1] 303878 0
H001789

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
Trial website
Not yet established
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 95098 0
Prof Bruce Taylor
Address 95098 0
Menzies Institute for Medical Research
University of Tasmania
Medical Sciences
Liverpool Street
Hobart
Tas 7000
Country 95098 0
Australia
Phone 95098 0
+61 03 62267700
Fax 95098 0
Email 95098 0
bruce.taylor@utas.edu.au
Contact person for public queries
Name 95099 0
Prof Bruce Taylor
Address 95099 0
Menzies Institute for Medical Research
University of Tasmania
Medical Sciences
Liverpool Street
Hobart
Tas 7000
Country 95099 0
Australia
Phone 95099 0
+61 03 62267700
Fax 95099 0
Email 95099 0
bruce.taylor@utas.edu.au
Contact person for scientific queries
Name 95100 0
Prof Bruce Taylor
Address 95100 0
Menzies Institute for Medical Research
University of Tasmania
Medical Sciences
Liverpool Street
Hobart
Tas 7000
Country 95100 0
Australia
Phone 95100 0
+61 03 62267700
Fax 95100 0
Email 95100 0
bruce.taylor@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
What supporting documents are/will be available?
No other documents available
Summary results
No Results