Eye MOvement DesensItisation and Reprocessing Therapy (EMDR) for FunctIonal Neurological Disorder (FND)

NCT05455450 | Completed

• 1 other identifier: COPS1001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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 posttraumatic 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 to attend therapy in-person or via an online video conferencing platform. Participants will complete questionnaires regarding 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 experiences of treatment.

Conditions

Functional Neurological Symptom Disorder

Keywords

Functional neurological disorder, FND

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Percentage of potentially eligible participants attending screening interview

  12 months (recruitment stage)

• Intervention adherence

  Percentage of participants randomised to EMDR+NPC who complete therapy

  18 months (intervention stage)

• Outcome measures completion

  Percentage of participants who complete outcome measures at all 4 time points

  12 months (9-month follow-up stage)

Secondary Outcomes (8)

• EQ-5D-5L

  4 time points over 9 months (trial period)

• Ecological Momentary Assessment (EMA) of FND symptoms

  4 time points over 9 months (trial period)

• PHQ-9

  4 time points over 9 months (trial period)

• GAD-7

  4 time points over 9 months (trial period)

• International Trauma Questionnaire (ITQ)

  4 time points over 9 months (trial period)

Study Arms (2)

EMDR + NPC

EXPERIMENTAL

8-16 eye movement desensitisation and reprocessing therapy (EMDR) sessions, plus 1 month follow up session after the therapy has ended. Participants will also attend neuropsychiatric follow-up appointments as part of standard medical care.

Other: Eye movement desensitisation and reprocessing therapy; Other: Neuropsychiatric care

Neuropsychiatric Care (NPC)

OTHER

Standard medical care

Other: Neuropsychiatric care

Interventions

Eye movement desensitisation and reprocessing therapy OTHER

Up to 16 EMDR sessions (minimum of 8 sessions), and 1-month follow-up session, as well as attending neuropsychiatric appointments (NPC). Participants will be given the choice of attending EMDR physically face-to-face or virtually via a video-consultation platform. Sessions will normally be attended weekly, with treatment completed within 6 months. Sessions will be 60-90 minutes long. EMDR will follow the standard 8-phase protocol, with additions so that it is tailored for FND presentations. The FND-specific EMDR therapy protocol has been developed for the trial by the chief investigator.

Also known as: EMDR

EMDR + NPC

Neuropsychiatric care OTHER

Standard medical care consisting of 1-3 30 minute appointments with neuropsychiatrist over the course of the 9-month trial period.

EMDR + NPC; Neuropsychiatric Care (NPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Predominant diagnosis of functional seizures and/or functional motor disorder, with diagnosis confirmed by neurologist
• Aged 18 years or over
• Capacity to consent
• Willingness to attend regular psychological therapy sessions
• Reporting at least 1 traumatic event on the International Trauma Exposure Measure

You may not qualify if:

• Non-English speaking
• Current ongoing adversity that is likely to interfere with psychological therapy, e.g. domestic violence, homelessness, unresolved compensation claim/litigation
• Predominant diagnosis of Borderline Personality Disorder\*
• Predominant diagnosis of chronic pain condition\*, e.g. fibromyalgia
• Predominant diagnosis of chronic fatigue syndrome\*
• Diagnosis of a psychotic disorder
• Diagnosis of Dissociative Identity Disorder or score in clinical range on "identity disturbance" subscale of Multiscale Dissociation inventory
• Uncontrolled epileptic seizures
• Diagnosis of an eating disorder
• Current severe self harm or strong suicidal ideation that requires secondary care mental health services input
• Current alcohol or drug harmful-use or dependence
• Current diazepam use exceeding the equivalent of 10mg per day
• Currently attending individual psychological therapy focused on functional neurological disorder or other specialist functional neurological disorder-specific treatment such as inpatient/outpatient multi-disciplinary treatment or intensive functional neurological disorder-specific physiotherapy
• Comorbid diagnosis is acceptable, as long as functional neurological disorder is the predominant difficulty

Sponsors & Collaborators

• South West London and St George's Mental Health NHS Trust: lead

Study Sites (2)

South West London & St George's NHS Trust

London, SW17 7DJ, United Kingdom

Location

Neuropsychiatry Service

London, SW170QT, United Kingdom

Location

Related Publications (2)

• Cope SR, Smith JG, El-Leithy S, Vanzan S, Hogwood P, Golder D, Turner KJ, Crowley M, Billings J, Pick S, Pentland C, Edwards MJ. Randomised feasibility study evaluating eye movement desensitisation and reprocessing therapy for functional neurological disorder (MODIFI). J Neurol. 2025 Jul 8;272(8):493. doi: 10.1007/s00415-025-13219-5.

  PMID: 40627223 DERIVED

• Cope SR, Smith JG, El-Leithy S, Vanzan S, Pentland C, Pick S, Golder D, Hogwood P, Turner K, Billings J, Edwards MJ. MODIFI: protocol for randomised feasibility study of eye-movement desensitisation and reprocessing therapy (EMDR) for functional neurological disorder (FND). BMJ Open. 2023 Jun 2;13(6):e073727. doi: 10.1136/bmjopen-2023-073727.

  PMID: 37270188 DERIVED

MeSH Terms

Conditions

Conversion Disorder; Frontonasal dysplasia

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sarah R Cope, DClinPsy

  South West London & St. George's Mental Health NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessing RA and project statistician will be blind to treatment allocation.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised into EMDR (plus neuropsychiatric care; NPC) or NPC. A stratified block randomisation will be used to ensure similar numbers of patients with predominant functional seizures or functional motor disorder, and PTSD/non-PTSD are relatively equal across arms.

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: July 13, 2022
• Study Start: November 7, 2022
• Primary Completion: August 31, 2024
• Study Completion: May 31, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)