The TMS4MS Feasibility Trial
Research type
Research Study
Full title
A Feasibility Trial of Neuromodulation with Connectivity-Guided Intermittent Theta Burst Stimulation for Cognitive Impairment in Multiple Sclerosis
IRAS ID
295754
Contact name
Robert A Dineen
Contact email
Sponsor organisation
The University of Nottingham
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Cognitive difficulties can affect many people who live with multiple sclerosis (MS). These difficulties, such as within thinking, memory, and problem solving, can have an impact on important aspects of an individual’s life, including their daily activities, work, and how they manage their condition. Previous studies have suggested that cognitive difficulties affect approximately 40-70% of people living with MS, yet there are currently no treatments to target these problems.
Recent research has directed towards a non-invasive intervention which stimulates a part of the brain (called the dorsolateral prefrontal cortex, or DLPFC for short) which is reported to participate in cognitive processes, such as memory, thinking, and attention. This intervention, called “intermittent theta burst stimulation” (iTBS), involves placing a magnetic device to the skull to activate the DLPFC underneath. This technique has been used successfully in the treatment of depression and is widely considered safe and painless. Previous studies have also shown that iTBS intervention can lead to improvements in cognitive processes.
Before we can progress to a large trial to explore its clinical effectiveness for reducing cognitive problems for people with MS, we need to clarify some aspects regarding its feasibility, for example whether it is an acceptable intervention for people with MS.
We will conduct a single-centre, mixed methods feasibility randomised controlled trial to compare four groups (10 participants each) of iTBS administration: Group 1: 4 administrations of iTBS over 1 week; Group 2: 8 administrations of iTBS over 2 weeks; Group 3: 16 administrations of iTBS over 4 weeks; Group 4: 8 administrations of sham iTBS over 2 weeks. Following participation, we will interview selected participants to explore their experiences of the trial, including the tolerability of the protocol and acceptability of the visit schedule, and any differences in cognition and host a post-participation workshop for all participants.REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0506
Date of REC Opinion
20 Aug 2021
REC opinion
Further Information Favourable Opinion