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CompletedNCT05455450MODIFIUpdated Sep 16, 2025

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

An interventional study of Eye movement desensitisation and reprocessing therapy and Neuropsychiatric care in Functional Neurological Symptom Disorder, sponsored by South West London and St George's Mental Health NHS Trust. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by South West London and St George's Mental Health NHS Trust · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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:

I. Test the acceptability and feasibility of an FND-specific EMDR intervention protocol, delivered physically or virtually.

II. 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.

III. 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 on trial experiences. The interviews will be analysed using reflexive thematic analysis.

02

Conditions studied

  • Functional Neurological Symptom Disorder

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Keywords

  • Functional neurological disorder, FND
03

In context

Conversion Disorder

89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.

This study's enrollment of 50 is above the median of 38 across 51 interventional studies indexed under Conversion Disorder.

Browse Conversion Disorder studies →

Lead sponsor

South West London and St George's Mental Health NHS Trust is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Non-English speaking
  2. Current ongoing adversity that is likely to interfere with psychological therapy, e.g. domestic violence, homelessness, unresolved compensation claim/litigation
  3. Predominant diagnosis of Borderline Personality Disorder*
  4. Predominant diagnosis of chronic pain condition*, e.g. fibromyalgia
  5. Predominant diagnosis of chronic fatigue syndrome*
  6. Diagnosis of a psychotic disorder
  7. Diagnosis of Dissociative Identity Disorder or score in clinical range on "identity disturbance" subscale of Multiscale Dissociation inventory
  8. Uncontrolled epileptic seizures
  9. Diagnosis of an eating disorder
  10. Current severe self harm or strong suicidal ideation that requires secondary care mental health services input
  11. Current alcohol or drug harmful-use or dependence
  12. Current diazepam use exceeding the equivalent of 10mg per day
  13. 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    EMDR + NPC

    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

  • Other
    Neuropsychiatric Care (NPC)

    Standard medical care

    Other: Neuropsychiatric care

Interventions

  • OtherEye movement desensitisation and reprocessing therapy

    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

  • OtherNeuropsychiatric care

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

06

What researchers measure

Primary outcomes

  1. Recruitment rate

    Percentage of potentially eligible participants attending screening interview

    Time frame: 12 months (recruitment stage)

  2. Intervention adherence

    Percentage of participants randomised to EMDR+NPC who complete therapy

    Time frame: 18 months (intervention stage)

  3. Outcome measures completion

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

    Time frame: 12 months (9-month follow-up stage)

Secondary outcomes

  1. EQ-5D-5L

    Brief health questionnaire

    Time frame: 4 time points over 9 months (trial period)

  2. Ecological Momentary Assessment (EMA) of FND symptoms

    Using an App, FND symptoms will be rated in terms of frequency, severity, interference with daily functioning, associated distress and preoccupation with

    Time frame: 4 time points over 9 months (trial period)

  3. PHQ-9

    Self-rated measure of depression

    Time frame: 4 time points over 9 months (trial period)

  4. GAD-7

    Self-rated measure of anxiety

    Time frame: 4 time points over 9 months (trial period)

  5. International Trauma Questionnaire (ITQ)

    Measure of PTSD and Complex PTSD

    Time frame: 4 time points over 9 months (trial period)

  6. Multiscale Dissociation Inventory

    Measure of dissociation

    Time frame: 4 time points over 9 months (trial period)

  7. Adult Service Use Schedule (AD-SUS)

    Self-report measure of service use

    Time frame: 2 time points over 9 months (trial period)

  8. World Health Organisation Disability Assessment Schedule (WHODAS 2.0)

    Health-Related Quality of life/functioning measure

    Time frame: 4 time points over 9 months (trial period)

07

Study locations

2 sites
  • South West London & St George's NHS Trust
    London, SW17 7DJ, United Kingdom
  • Neuropsychiatry Service
    London, SW170QT, United Kingdom
08

References and documents

Publications

  • Pritomanova I, Cope SR, James B, Edwards MJ, Smith JG, El-Leithy S, Vanzan S, Hogwood P, Golder D, Turner KJ, Billings J. The journey to diagnosis and care of functional neurological disorder (FND). PLoS One. 2026 Apr 22;21(4):e0328321. doi: 10.1371/journal.pone.0328321. eCollection 2026. PubMed 42018562 ↗
  • 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. PubMed 40627223 ↗
  • 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. PubMed 37270188 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2022 to primary completion in Aug 2024, 21 months.

Of 34 interventional studies with no phase under Conversion Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2022
First posted
Jul 13, 2022
StartActual
Nov 7, 2022
Primary completionActual
Aug 31, 2024
CompletionActual
May 31, 2025
Last update
Sep 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05455450
Lead sponsor
South West London and St George's Mental Health NHS Trust
Responsible party
Sponsor
First posted
Jul 13, 2022
Start date
Nov 7, 2022
Primary completion
Aug 31, 2024
Completion
May 31, 2025
Last update
Sep 16, 2025

Study contacts

Sarah R Cope, DClinPsy
principal investigator · South West London & St. George's Mental Health NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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