A phase II trial examining the safety and preliminary efficacy of repetitive transcranial magnetic stimulation (rTMS) for people living with multiple sclerosis

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12622000064707
• Lead Sponsor: niversity of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-20
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Diagnosed of Multiple Sclerosis (MS) by a neurologist,
Has been stable (on or off MS treatment) and relapse free for 6 months
Extended Disability Status Scale (EDSS) between 1.5 and 6
Has capacity to provide informed consent
Able to travel to site every weekday for 4 weeks

Exclusion Criteria

Have metal inside their head or body (i.e. cardiac pacemaker)
Pregnant or intend to become pregnant
Have a history of seizures, epilepsy, serious head trauma*, substance abuse*, stroke, brain surgery, bipolar, mania, claustrophobia or migraines
Have an EDSS < = 1 and > = 6.5
Previously received rTMS 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 PI discretionary basis, e.g. these conditions are prevalent in the community and may not be clinically significant. **English illiterate participants who can provide a suitable translator/interpreter for the duration of the study (including phone calls, questionnaires, and visits) may be included.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Multiple Sclerosis functional composite score (includes timed 25-foot walk, 9-hole peg test and Symbol Digit Modalities Test) between rTMS and placebo groups[ From baseline to 4 weeks post randomization. The assessment will be made once at baseline, visit 10 (2 weeks post randomization) and visit 20 (4 weeks post randomization).]