Using brain stimulation to improve cognitive function in people with multiple sclerosis

A Feasibility Trial of Neuromodulation With Connectivity-Guided Intermittent Theta Burst Stimulation for Cognitive Impairment in Multiple Sclerosis

This study is testing if a brain stimulation technique can help improve thinking skills in people with multiple sclerosis who have trouble with cognitive function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: University of Nottingham (other)
• Locations: 1 site (Nottingham, Nottinghamshire)
• Trial ID: NCT04931953 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility of using intermittent theta burst stimulation (iTBS) to enhance cognitive function in individuals with multiple sclerosis (MS) who experience cognitive impairment. Participants will be randomly assigned to receive either active iTBS targeting the dorsolateral prefrontal cortex or a sham treatment over a period of up to four weeks. The study aims to assess the acceptability and tolerability of the intervention, as well as participant adherence to the treatment schedule. Follow-up assessments will be conducted eight weeks after the intervention to evaluate the willingness of participants to complete the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-69 with a diagnosis of multiple sclerosis and reported cognitive difficulties.

Not a fit: Patients with significant depression, other neurological conditions, or contraindications to MRI or TMS may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new non-invasive treatment option for cognitive impairment in patients with multiple sclerosis.

How similar studies have performed: Previous studies have shown success with similar brain stimulation techniques in treating cognitive issues, but this specific application in MS is novel.

Eligibility 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.

Where this trial is running

Nottingham, Nottinghamshire

• Queen's Medical Centre — Nottingham, Nottinghamshire, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Robert A Dineen

Conditions: Multiple Sclerosis, Cognitive Impairment