Brief summary

Participants will be asked to attend 23 study appointments over a total of 4 months (2 for magnetic resonance imaging (MRI) and 20 for magnetic brain stimulation (MBS or placebo sessions and 1 for screening). The screening visit will include a full medical history and physical examination and will take about an hour. Each MRI visit is expected to take about 60 minutes. Each MBS or placebo visit is expected to take about 15 minutes including assessment of adverse event and medications. The first and last two visits will include completion of questionnaires (including quality of life, anxiety and depression, fatigue, cognitive and sleep assessments) which will take an additional 30 minutes in total.

All study visits (except for MRI) will be at the Medical Sciences Precinct (MSP), University of Tasmania and four other participating centers (Melbourne, Newcastle in NSW, Launceston in Tasmania and Perth) around Australia. Each MRI will be conducted by a trained technician at a hospital. Two additional appointments will be conducted over the phone, the pre-screening visit (Visit 0) and the final follow up (visit 21).

The aims of the study are;
1. to explore any potential benefit to cognitive and motor function
2. to determine if low intensity MBS is effective and safe in people with MS
3. to explore any potential benefit to quality of life, anxiety and depression, fatigue, and sleep quality
4. to determine if there is any evidence of myelin repair following MBS (using MRI measurements)
5. to determine if the placebo protocol maintains sufficient participant blinding

Inclusion criteria

A person will be eligible to participate if they are age 18-65 with MS; diagnosed by an MS neurologist, has been stable (on or off MS treatment) and relapse free for 6 months, with an Extended Disability Status Scale (EDSS) between 1.5 and 6 (both numbers inclusive); willing and able to travel to clinical/study site every weekday for 4 weeks and has capacity to provide informed consent.

Exclusion criteria

A person will be ineligible to participate if they:
• have metal inside their head or body (i.e. cardiac pacemaker) as metal may be affected by the magnetic field generated by MBS but will certainly respond to the magnetic field generated by MRI.
• are pregnant or intend to become pregnant, as the known influence of pregnancy hormones on myelination, remyelination and MS relapse would confound the interpretation of our study;
• have a history of seizures, epilepsy, serious head trauma*, substance abuse*, stroke, brain surgery, bipolar, mania, claustrophobia or migraines* (including receiving tricyclic antidepressants or neuroleptic agents for the treatment of any indications listed here).
• have an EDSS less than 1.5 or more than 6. This exclusion criteria ensures that all participants are mobile and require no more than a walking cane for support.
• Previously received MBS therapy
• English illiterate (to enable completion of follow up questionnaires)
• Currently involved in another interventional clinical trial

*Note: participants with minor/moderate head trauma, previous substance abuse and/or well controlled or rare migraines may be included on Principal Investigator’s discretionary basis

Anticipated start date

June 2022

Recruitment contacts

Julie Sansom, Clinical Trials Study Coordinator, Multiple Sclerosis (MS)
Email: julie.sansom@utas.edu.au
Ph: (03) 6226 2752

Dr Vincent Chigozie Ezegbe, Clinical Research Fellow, Multiple Sclerosis (MS) Flagship
Email: vincent.ezegbe@utas.edu.au
Ph: (03) 6226 4236

Mr Amin Zarghami, Graduate Research Student
Email: Amin.Zarghami@utas.edu.au
Ph: (03) 6226 4656

Further details

Full details of the trial can be found on the ANZCTR clinical trials database or clinicaltrials.gov: ACTRN12622000064707

Region

NSW, VIC, WA, TAS (Coordinating site)

Ethics Approval

Yes (Tasmania). For other participating sites ethics application made under National Mutual Agreement.

Last updated

20/05/2022