Feasibility of Neuromodulation With Connectivity-Guided iTBS for Cogni
A Feasibility Trial of Neuromodulation With Connectivity-Guided Intermittent Theta Burst Stimulation for Cognitive Impairment in Multiple Sclerosis
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Intermittent theta burst stimulation (iTBS)
Placebo
- Sham Intermittent theta burst stimulation (iTBS)
What it measured
Main measures
Feasibility of Trial Procedures
8 weeks
Feasibility
Other measures (31)
Feasibility of recruitment
1 week
FeasibilityThe Brief Visuospatial Memory Test Revised (BVMT-R) Trials 1-3.
8 weeks
Thinking and memoryThe Brief Visuospatial Memory Test Revised (BVMT-R) Total learning
8 weeks
Thinking and memoryThe Brief Visuospatial Memory Test Revised (BVMT-R) Learning
8 weeks
Thinking and memoryThe Brief Visuospatial Memory Test Revised (BVMT-R) Delayed recall
8 weeks
Thinking and memoryThe Brief Visuospatial Memory Test Revised (BVMT-R) Percent retained
8 weeks
Thinking and memoryThe Brief Visuospatial Memory Test Revised (BVMT-R) Recognition hits
8 weeks
Thinking and memoryThe Brief Visuospatial Memory Test Revised (BVMT-R) Recognition false alarms
8 weeks
Thinking and memoryThe Brief Visuospatial Memory Test Revised (BVMT-R) Recognition discrimination index
8 weeks
Thinking and memoryThe Brief Visuospatial Memory Test Revised (BVMT-R) Recognition response bias
8 weeks
Thinking and memory
Who could take part
MS (type not specified) · 18 to 69
Show the full criteria
Inclusion criteria
* Aged between 18 - 69 years. * Received a diagnosis of MS (any type of MS) at least 12 months prior to baseline assessment. * Report cognitive problems, as determined by a cut-off score of 55 or lower on the oral SDMT * Ability to give informed consent * Able to commit to regular attendance in clinic, for up to 4 times a week for 4 weeks and follow up appointment eight weeks after the end of trial procedures.
Exclusion criteria
* Diagnosed with depression or scores ≥15 on the Patient Health Questionnaire-9 * Medical history of, or self-reported, seizures * Neurological conditions (in addition to MS), e.g., brain neoplasm, cerebrovascular events, epilepsy, prior brain injury or brain surgery * Contraindications to MRI scanning (identified by standard MRI safety screening questionnaire). * Contraindications to TMS, including hairstyles or piercings that would impair magnetic transmission which cannot be altered to ensure effective intervention * Frequent panic attacks which are likely to prevent regular attendance or participation in MRI/TMS procedures * Prior TMS intervention * Pregnancy * MS relapse within the preceding 6 weeks * Significant mobility problems if they are likely to preclude regular attendance in clinic, for up to 4 times a week for 4 weeks * Involved with any other clinical trials involving medical procedures, interventions or treatment.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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 the investigators can progress to a large trial to explore its clinical effectiveness for reducing cognitive problems for people with MS, some aspects regarding its feasibility need to be clarified, for example whether it is an acceptable and tolerable intervention for people living with MS. A single-centre, mixed methods feasibility randomised controlled trial will be conducted to compare four groups (10 participants each) of iTBS administration. At baseline, End of Intervention (EOI), and 8-week follow up, the investigators will complete outcome measures to evaluate cognition, mood and fatigue. Participants will also undergo MRI scans at baseline and EOI. Following participation, participants will be interviews and the investigators will organise a post-participation workshop to explore their experiences of the trial, including the tolerability of the protocol and acceptability of the visit schedule, and any differences in cognition.
Papers
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History
Started
Jun 2022
Main results due
Aug 2023
Finished
Dec 2023