Title: Randomised feasibility study of eye movement desensitisation and reprocessing therapy for functional neurological disorder
Funder: Department of Health and Social Care

Abstract: Background Functional neurological disorder (FND) refers to an involuntary loss of control over and/or aberrant perception of the body. Common presenting symptoms are functional (non-epileptic) seizures, and functional motor disorder, e.g. walking difficulties, weakness, or tremor. Treatment in the United Kingdom is inconsistently available, and there is inequity of care compared to other neurological conditions. There are no established standards of care for this patient group. FND is associated with large health- and social-care costs. Greater access to effective treatments would lead to reduced distress and disability for patients with FND; and reduce unnecessary costs to the NHS. This research proposes using eye-movement desensitisation and reprocessing therapy (EMDR) as a treatment for FND. EMDR is an evidence-based treatment for post-traumatic stress disorder (PTSD), but its use for other conditions is growing. A FND-specific EMDR protocol will be developed and tested, and if the intervention proves feasible with promising clinical outcomes, progression to a substantive study could take place. Aims and Objectives Test the acceptability and feasibility of an FND-specific EMDR intervention protocol, delivered physically or virtually. Investigate the value of a range of outcome measures, to determine the outcome measure with greatest symptom improvement and the required sample size, for a substantive RCT. Carry out semi-structured interviews with participants and therapists to explore experiences of EMDR and the trial; informing the intervention and design for a substantive trial. Methods 50 adult patients with a diagnosis of FND will be recruited via a Neuropsychiatry Service. The study will be a single-blind randomised controlled trial (RCT) with two arms: EMDR (plus standard neuropsychiatric care; NPC) and standard NPC. The two groups will be compared at baseline (T0), 3 months (T1), 6 months (T2), and 9 months (T3). Measures of feasibility include safety, recruitment, retention, and treatment adherence and acceptability. Clinical outcome measures assess health-related functioning/quality of life, FND, depression, anxiety, PTSD, dissociation, service-utilisation and other costs. Patient-rated improvement and satisfaction will also be assessed. Feasibility outcomes will be summarised using descriptive statistics. Exploratory analyses using (linear/logistic) Mixed Effect Models will examine the rate of change in intervention and control groups clinical outcome measures across the four time-points After the intervention period, a sample of participants, and clinicians, will be invited to attend semi-structured interviews about their trial experiences. The interviews will be analysed using reflexive thematic analysis. Timelines for delivery The trial will take 36 months, including study set-up, recruitment and data collection, data analysis, writing up and submission, and development of protocol for substantive study. Anticipated Impact and Dissemination Dissemination will occur via patient charities, scientific meetings and conferences, and journal publications. If the trial proves to be feasible, and the clinical results suggest possible benefit, progression to a substantive trial could take place. This is likely to be a multicentre, pragmatic parallel group RCT. Success in a substantive trial would inform standards of care and could result in a wider delivery of EMDR as an FND treatment-option. This would improve patient care, clinical outcomes, and result in NHS savings.

Lay abstract: Background: Functional Neurological Disorder (FND) is a problem with the functioning of the nervous system and how the brain and body send and receive signals, rather than due to neurological disease or injury. This causes a range of neurological symptoms such as seizures, shaking, weakness, and paralysis. The symptoms are associated with significant distress and disability. Treatment for FND in the United Kingdom is limited, and the evidence-base for treatment is poor, despite it being a common presentation. A psychological therapy called cognitive-behavioural therapy has been found to be beneficial, but it does not help everyone. Eye movement desensitisation and reprocessing therapy (EMDR) is a psychological therapy that focuses on distressing memories from the past, as well as distressing images related to the present or future that are connected to a person s difficulties. During EMDR, a person brings a target memory or image to mind whilst the clinician creates a distracting task that means the person s attention is divided. Traditionally, eye-movements are used as the distracting task. EMDR is an effective and established treatment for post-traumatic stress disorder, but it can also be helpful with many other conditions, such as persistent pain. There is a small amount of case study evidence that EMDR can be useful at treating FND, but proper scientific evaluation is needed. Aims: This research aims to evaluate the possibility of delivering, and potential benefit, of EMDR as a psychological therapy for functional neurological disorder. If the study shows that it is feasible and potentially beneficial, a larger trial will be designed. Design and Methods: The study will recruit 50 participants who have specific functional neurological symptoms: weakness, walking difficulties, jerks, shaking, and/or seizures from a Neuropsychiatry Service. Participants will be allocated to either EMDR, and routine medical appointments, or to routine medical appointments alone. Allocation will be carried out by a computer programme. Those allocated to EMDR will be offered 10-16 weekly therapy sessions with a clinical psychologist, completed within 6 months, and follow-up session 1 month after therapy has ended. Participants will be able to choose whether they attend therapy in-person or via an online video conferencing platform. Participants will complete questionnaires regarding their health-related functioning, FND, mental health, and healthcare utilisation. These questionnaires will be completed at the beginning, 3 months, 6 months, and 9 months. Some participants will be asked to take part in interviews about their experiences of treatment. Patient and Public Involvement: Patients have reviewed this proposed study and are supportive of it. Three patient representatives will review any participant literature, input into participant interview questions, and be part of the research meetings. We will publish the results of the study, share results on patient websites and at academic events.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: NEUROLOGICAL