Trial protocol: Feasibility of neuromodulation with connectivity-guided intermittent theta-burst stimulation for improving cognition in multiple sclerosis
Blanchard Caroline,
De Dios Perez Blanca,
Tindall Tierney,
Clarkson Katie,
Felmban Ghadah,
Scheffler-Ansari Grit,
Periam Roger,
Lankappa Sudheer,
Constantinescu Cris S.,
das Nair Roshan,
Morriss Richard,
Evangelou Nikos,
Auer Dorothee P.,
Dineen Rob A.
Affiliations
Blanchard Caroline
Radiological Sciences, Academic Unit of Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom
De Dios Perez Blanca
Radiological Sciences, Academic Unit of Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom
Tindall Tierney
Radiological Sciences, Academic Unit of Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom
Clarkson Katie
Radiological Sciences, Academic Unit of Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom
Felmban Ghadah
Radiological Sciences, Academic Unit of Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom
Scheffler-Ansari Grit
Patient and Public Involvement (PPI) Representatives., c/o Academic Unit of Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom
Periam Roger
Patient and Public Involvement (PPI) Representatives., c/o Academic Unit of Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom
Lankappa Sudheer
Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, United Kingdom
Constantinescu Cris S.
Clinical Neurology, Academic Unit of Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom
das Nair Roshan
Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom
Morriss Richard
NIHR Nottingham Biomedical Research Centre, Nottingham, United Kingdom
Evangelou Nikos
Clinical Neurology, Academic Unit of Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom
Auer Dorothee P.
Radiological Sciences, Academic Unit of Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom
Dineen Rob A.
Radiological Sciences, Academic Unit of Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom
Cognitive impairment in multiple sclerosis (MS) can adversely impact participation in employment, activities of daily living, and wider society. It affects 40–70% of people living with MS (pwMS). There are few effective treatments for cognitive impairment in people with MS. Neuromodulation with intermittent theta-burst stimulation (iTBS) has potential for treating cognitive impairment in pwMS. This single-centre mixed-methods feasibility randomised controlled trial (NCT04931953) will assess feasibility, acceptability, and tolerability of procedures used for applying iTBS for improving cognitive performance in pwMS. Participants will be randomised into three intervention groups with varying lengths of iTBS treatment (from 1 to 4 weeks) and a sham-control group. Quantitative data will be collected at three time points (baseline, end of intervention, and 8-week follow-up). End of the intervention semi-structured interviews will explore the views and experiences of the participants receiving the intervention, analysed using framework analysis. Quantitative and qualitative data will be synthesised to explore the impact of the iTBS intervention. Ethical approval has been received from the Health Research Authority (21/LO/0506) and recruitment started in June 2022. The results will inform the design of an RCT of the efficacy of iTBS as a therapeutic intervention for cognitive impairment in pwMS.
