Functional neurological disorder Mental and Behavioural Disorders
Conditions
Interventions
This project employs a mixed, controlled, factorial group design with the between-subject factor group (functional neurological disorder (FND) versus non-clinical controls (NCC)) and the within-subjec
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For non-clinical (healthy) controls 1. Aged from 18-65 years old 2. Fluency in English to understand the study instructions For participants with lived experience of FND: 1. Aged from 18-65 years old 2. Fluency in English to understand the study instructions 3. Diagnosis of Functional Neurologic Disorder (FND) as defined in ICD-10 (FND with motor or sensory symptoms (ICD-10 F44.4 and 44.6), seizures (F44.5), or mixed symptoms (F44.7) or according to the diagnostic classification of DSM-5
Exclusion criteria
Exclusion criteria: For all participants: 1. Diagnosis of major comorbid cardiovascular (e.g., heart disease) 2. Medical electrical implants, e.g., a pacemaker or implanted pumps, having implanted metals in the nondominant hand or arm, where the electrical pulses are applied 3. Pregnancy 4. Practical reasons against study participation: Physical symptoms / disability impairing ability to participate (e.g., severe/constant tremor, bilateral upper limb paralysis, multiple daily seizures) 5. Presence of a skin condition, scarring/tattoos on the left volar forearm at site of stimulation 6. Significant pain on the non-dominant volar forearm where pulses are to be applied during the 3 days before testing 7. Any aversion to receiving mild electrical pulses 8. Any aversion to experiencing pain during the experiment For non-clinical controls: To ensure the definition as non-clinical controls: Diagnosis of FND; active major physical or mental health disorder For participants with lived experience of FND: To minimize the risk of the experiment and avoid distortion on the physiological pain perception and/or would impair the ability to participate: active severe psychiatric disturbance (e.g., psychosis, alcohol, or substance dependence) or neurological (e.g., epilepsy, multiple sclerosis, Complex Regional Pain Syndrome (CRPS) in the tested arm) disorder that would either confound the findings or impair the participant’s ability to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures are assessed using a Visual Analogue Scale (VAS) between 0-100 repetitively measured in the single lab visit during phases 2 and 4: 1. Pain intensity after each pain stimulus in each phase 2. Prior pain expectation at the beginning of each phase and again after every block of 4 pain stimuli within a phase 3. Prior pain expectation certainty at the beginning of each phase and again after every pain stimuli within a phase | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are all assessed during the single lab visit: The following outcomes are repetitively measured, once before phase 2 and once before phase 4: 1. Prior anxiety measured using a Visual Analogue Scale (VAS) between 0-100 at the beginning of each phase 2. Prior anxiety certainty measured using a Visual Analogue Scale (VAS) between 0-100 once at the beginning of each phase 3. State anxiety measured using the State-Trait Anxiety Inventory (STAI) (short 6-item-version: STAI-6) once at the beginning of each phase 4. Psychometric and health-related variables will be measured using the following questionnaires once in the single lab visit : 4.1. Functional Neurological Symptoms Questionnaire (FNSQ) 4.2. Brief illness perception questionnaire (B-IPQ) 6 4.3. Widespread Pain Index (WPI) 4.4. Pain Frequency Intensity and Burden Scale (P-FIBS) 4.5. Patient Health Questionnaire (PHQ-8) 4.6. Somatosensory amplification scale (SSAS) 4.7. Pain Vigilance and Awareness Questionnaire (PVAQ) 4.8. Generalized Anxiety Disorder (GAD-7 Anxiety) 13 4.9. Brief Autism-Spectrum Quotient, AQ-10+SM-4 4.10. Brief Dissociative Experience Scale (B-DES) 4.11. Fear of Pain Questionnaire – short (FPQ-9) 4.12. Pain Catastrophizing Scale (PCS) 4.13. Brief Suggestibility Scale (BSS) | — |
Countries
England, United Kingdom
Contacts
Public ContactLivia Asan
Outcome results
None listed