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

Functional Neurological Symptom Disorder Clinical Trial

— MODIFI  

Official title:

Randomised Feasibility Study of Eye Movement Desensitisation and Reprocessing Therapy (EMDR) for Functional Neurological Disorder (FND)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05455450
• Other study ID #: COPS1001
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: March 2024
• Source: South West London and St George's Mental Health NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Neurological Symptom Disorder
• Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Neuropsychiatry Service	London

Sponsors (1)

Lead Sponsor	Collaborator
South West London and St George's Mental Health NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Percentage of potentially eligible participants attending screening interview	12 months (recruitment stage)
Primary	Intervention adherence	Percentage of participants randomised to EMDR+NPC who complete therapy	18 months (intervention stage)
Primary	Outcome measures completion	Percentage of participants who complete outcome measures at all 4 time points	12 months (9-month follow-up stage)
Secondary	EQ-5D-5L	Brief health questionnaire	4 time points over 9 months (trial period)
Secondary	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	4 time points over 9 months (trial period)
Secondary	PHQ-9	Self-rated measure of depression	4 time points over 9 months (trial period)
Secondary	GAD-7	Self-rated measure of anxiety	4 time points over 9 months (trial period)
Secondary	International Trauma Questionnaire (ITQ)	Measure of PTSD and Complex PTSD	4 time points over 9 months (trial period)
Secondary	Multiscale Dissociation Inventory	Measure of dissociation	4 time points over 9 months (trial period)
Secondary	Adult Service Use Schedule (AD-SUS)	Self-report measure of service use	2 time points over 9 months (trial period)
Secondary	World Health Organisation Disability Assessment Schedule (WHODAS 2.0)	Health-Related Quality of life/functioning measure	4 time points over 9 months (trial period)