Randomised feasibility study of EMDR for FND (MODIFI) version 1
Research type
Research Study
Full title
Randomised feasibility study of eye movement desensitisation and reprocessing therapy (EMDR) for functional neurological disorder (FND)
IRAS ID
311719
Contact name
Sarah R. Cope
Contact email
Sponsor organisation
South West London & St. George's Mental Health NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 31 days
Research summary
Research Summary
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. EMDR is an effective treatment for post-traumatic stress disorder, but it can also be helpful with other conditions. There is a small amount of case study evidence that EMDR can be useful at treating FND, but proper scientific evaluation is needed.
This research aims to evaluate the possibility of delivering, and potential benefit, of EMDR for FND. If the study shows that it is feasible and potentially beneficial, a larger trial will be designed. 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 EMDR, and routine medical appointments, or routine medical appointments alone. Allocation will be carried out by a computer programme. Those allocated to EMDR will be offered 8-16 weekly therapy sessions, 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 attend interviews about their experiences of treatment.
Summary of Results
Background Functional Neurological Disorder (FND) is a common and genuine disorder that can result in seizures and movement problems. This study explored if Eye Movement Desensitisation and Reprocessing (EMDR) therapy, designed to help people with upsetting or traumatic memories, could also be helpful. This "feasibility" study aimed to determine if a larger trial would be practical, and acceptable to participants.
Methods
Fifty participants with functional seizures and/or functional motor symptoms were randomly assigned to receive either FND-focused EMDR plus standard neuropsychiatric care (NPC) or NPC alone. We assessed recruitment rates, whether participants completed treatment, and completion of follow-up questionnaires at 3, 6, and 9 months.
We also checked for safety, participant satisfaction, and interviewed participants.Results
50 participants were recruited (58% of those referred to the study), 88% completed EMDR therapy, and there was good completion of follow-up assessments. Compared to NPC group, participants receiving EMDR reported greater satisfaction, and belief that they had been given the right treatment. No unexpected serious side effects occurred.
77% EMDR participants reported their primary FND symptom as very much or much improved, and overall, 95% reported some improvement. Those with functional seizures in the EMDR group experienced fewer seizures and more seizure-free days at the end of the study (Average weekly seizure frequency=5 vs NPC =11). Participants who received EMDR reported reduced severity of symptoms, daily interference, distress, and preoccupation with symptoms, compared to the NPC group. Additionally, they reported reductions in PTSD, depression, anxiety, dissociation, and disability. Healthcare-use also decreased in the EMDR group, while healthcare-use stayed the same or increased for the NPC group.Conclusion
This study showed FND-specific EMDR therapy is feasible and well-received. The preliminary positive effects on FND symptoms, mental health, disability, and healthcare-use provide a strong rationale for conducting a definitive, large-scale study to confirm its effectiveness.The main results paper has been published and can be found at https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Flink.springer.com%252Farticle%252F10.1007%252Fs00415-025-13219-5%2FNBTI%2Fll3AAQ%2FAQ%2F1636ccb6-c69f-4dc2-8e12-4c5ca6b9e86b%2F1%2FFu2LJ2x4Kg&data=05%7C02%7Cedgbaston.rec%40hra.nhs.uk%7Cb7b3a47a268e48a1577108ddff68c98e%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638947547724144246%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=zvHgs6QrFy3TvDFhIeJj7sw%2FlGaIafZYC83NLdWCC7s%3D&reserved=0
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0178
Date of REC Opinion
27 Sep 2022
REC opinion
Further Information Favourable Opinion