Clinical trial NCT05455450: Eye MOvement DesensItisation and Reprocessing Therapy (EMDR) for FunctIonal Neurological Disorder (FND)
Official title: Randomised Feasibility Study of Eye Movement Desensitisation and Reprocessing Therapy (EMDR) for Functional Neurological Disorder (FND)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Functional Neurological Symptom Disorder
Keywords: Functional neurological disorder, FND
Lead sponsor: South West London and St George's Mental Health NHS Trust
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 12 months (recruitment stage)
measure: Intervention adherence
timeFrame: 18 months (intervention stage)
measure: Outcome measures completion
timeFrame: 12 months (9-month follow-up stage)
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: 4 time points over 9 months (trial period)
measure: Ecological Momentary Assessment (EMA) of FND symptoms
timeFrame: 4 time points over 9 months (trial period)
measure: PHQ-9
timeFrame: 4 time points over 9 months (trial period)
measure: GAD-7
timeFrame: 4 time points over 9 months (trial period)
measure: International Trauma Questionnaire (ITQ)
timeFrame: 4 time points over 9 months (trial period)
measure: Multiscale Dissociation Inventory
timeFrame: 4 time points over 9 months (trial period)
measure: Adult Service Use Schedule (AD-SUS)
timeFrame: 2 time points over 9 months (trial period)
measure: World Health Organisation Disability Assessment Schedule (WHODAS 2.0)
timeFrame: 4 time points over 9 months (trial period)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Neuropsychiatry Service
Study officials:
affiliation: South West London & St. George's Mental Health NHS Trust
name: Sarah R Cope, DClinPsy
role: PRINCIPAL_INVESTIGATOR
References: