ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

multiple sclerosis

Condition category

Condition code

Neurological

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]

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]

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]

6 weeks post baseline visit

Secondary outcome [1]

Change in MRI remyelination measures between baseline and week 6 weeks of study.

Timepoint [1]

6 weeks after baseline visit

Secondary outcome [2]

Change in depression as measured by change in the HADS depression score at 6 weeks compared to baseline.

Timepoint [2]

6 weeks post baseline visit

Secondary outcome [3]

Change in cognition as measured by MS reactor at 6 weeks compared to baseline.

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

2/09/2019

Actual

Date of last participant enrolment

Anticipated

4/11/2019

Actual

Date of last data collection

Anticipated

20/12/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Multiple Sclerosis Research Australia

Address [1]

PO Box 625, North Sydney NSW 2059

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmanian Health and Medical research Committee

Ethics committee address [1]

Tasmanian Health and Medical research Committee University of Tasmania Private Bag 1 Sandy Bay Tasmania 7005

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/06/2019

Ethics approval number [1]

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

Prof Bruce Taylor

Address

Menzies Institute for Medical Research
University of Tasmania
Medical Sciences
Liverpool Street
Hobart
Tas 7000

Country

Australia

Phone

+61 03 62267700

Fax

bruce.taylor@utas.edu.au

Contact person for public queries

Name

Bruce Taylor

Address

Menzies Institute for Medical Research
University of Tasmania
Medical Sciences
Liverpool Street
Hobart
Tas 7000

Country

Australia

Phone

+61 03 62267700

Fax

bruce.taylor@utas.edu.au

Contact person for scientific queries

Name

Bruce Taylor

Address

Menzies Institute for Medical Research
University of Tasmania
Medical Sciences
Liverpool Street
Hobart
Tas 7000

Country

Australia

Phone

+61 03 62267700

Fax

bruce.taylor@utas.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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 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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Documents added manually

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