Making it Personal: Identifying personalised triggers of fatigue in multiple sclerosis using N-of-1 studies

Study Background

Multiple sclerosis (MS) is a condition of the central nervous system, where there is interference in the nerve impulses within the brain, spinal cord and optic nerves. Scars occur within the central nervous system and, depending on where they develop, manifest into various symptoms such as problems with motor control (muscle spasms, weakness, lack of coordination/balance and functioning of arms and legs) neuropsychological issues (memory loss and cognitive issues), bladder and bowel incontinence, and other neurological symptoms such as vertigo, pins and needles, neuralgia and visual disturbances. Fatigue is among the most commonly reported, most disabling but least understood symptom experienced by patients with MS. Patients differ in the symptoms they experience depending on where lesions have developed on the brain and spinal cord. MS affects over 25,600 of the Australia population. The burden of disease on the patient and their family/carers is high and the economic effect on the health system and wider economy is substantial.

There is currently no known cure for MS however there are numerous treatment options available to help manage symptoms and slow progression of the disease. The gold standard research design for testing treatments is the ‘randomised controlled trial’ (RCT). However, RCTs identify whether a treatment is effective for patients on average and provide less information about whether a treatment is effective for each individual patient in the trial. N-of-1 methods can be used to evaluate how individual patients respond to treatments and to understand how symptoms fluctuate over time, which may help self-management of the condition.

Study Aim

This study aims to assess the feasibility and acceptability of using N-of-1 methods to identify personalised patterns and predictors of fatigue and other MS symptoms at the individual patient level.

Study Design

This study involves a series of N-of-1 observational studies collecting daily data via an electronic diary for 6-12 weeks. Participants receive personalised feedback about patterns and triggers of fatigue at the end of the study. The data collected from this study will help to inform approaches for the management of symptoms and future research using similar research methods to test interventions for MS.

Ethical Approval

This study adheres to the Guidelines of the ethical review process of The University of Queensland and the National Statement on Ethical Conduct in Human Research. Ethics ID: 2018/HE000741.