Conversion disorder functional neurologic disorder
Conditions
Interventions
None listed
Sponsors
Elisabeth-Tweesteden ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with FND: - Age >= 18 years - Diagnosis of FND - Diagnosis is made by a neurologist - Diagnosis is based on, at least, clinical history and neurological examination Participants of all ethnic backgrounds, both female and male patients will be enrolled in this study. There is no upper age limit. Healthy controls (control group 1) - Age >= 18 years - Not having a psychiatric disorder - Not having a neurologic disease Participants of all ethnic backgrounds, both female and male patients will be enrolled in this study group. Neurological control group (Spinal disc herniation (SDH) / Migraine, control group 2) - Age >= 18 years, - Diagnosis of: o Spinal disc herniation, based on clinical symptoms and matching MRI-images o Migraine, formal diagnosis according to the Dutch guidelines. Diagnosis is made by neurologist Participants of all ethnic backgrounds, both female and male patients will be enrolled in this study group.
Exclusion criteria
Exclusion criteria: A potential participant will be excluded from participation in this study if one or more of the following criteria applies: • A known diagnosis of autism spectrum disorder (ASD) because, according to the DSM-5, verbal and non-verbal communication is often not well integrated in ASD, and this may interfere with the measurement of Anger-EMIN. • Psychotic disorder. Rationale: the negative symptoms of a psychotic disorder involve a reduction of emotional expression which may interfere with the results. • Impairment interfering with performing the tasks needed for the study (e.g., blindness, aphasia, severe tremor). • Not fluent in the Dutch language. Rationale: all questionnaires and tests are provided in Dutch. Participants who do not understand the Dutch language cannot participate. • Life expectancy of less than one year. • Refusal to informed consent. A medical history of neurological disorder, a previous episode of functional neurological complaints or another medical disorder is not exclusionary for the FND group. 4.3.2 Healthy controls A potential healthy control participant who meets any of the following criteria will be excluded from participation in this study: • Exclusion criteria as applied for FND. 4.3.3 Spinal disc herniation (SDH) / Migraine controls A potential neurological control participant who meets any of the following criteria will be excluded from participation in this study: • Exclusion criteria as applied for FND. • A current or prior diagnosis of FND. • Patients who daily use opiates or benzodiazepines A non-recent diagnosis of migraine and spinal disk herniation is not exclusionary because the FND-group can also include patients who do not have a first episode of FND.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter for the first objective is emotional incongruence. Emotional incongruence is quantified by the difference between self-reported emotion describing an unpleasant interpersonal interaction compared to an observable nonverbal expression of emotions. Observable nonverbal emotions will be quantified using facial expression of negative emotions using software-based analyses of digitized video recordings (FaceReader). This study will specifically focus on the emotion of self-reported and nonverbally expressed anger. The main study parameter for the secondary objective is the clinical course of FND-symptoms in patients with FND. The clinical course will be determined by the Clinical Global Impressions (CGI)-scale as primary outcome, and symptom status, quality of life and referral for FND-related intervention as secondary outcome measures. For the ancillary objectives, participants will also complete questionnaires to assess background psychological measures and the electronic patient records will be used to obtain clinical information relevant to FND. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters for primary objective 1 will be: - The congruency between the clinician observed anger and patient-reported anger will be measured by the clinical interview and the referring physician form assessed at T0. - The Anger-EMIN scores during the other phases of the interview, assessed at T0. Secondary study parameters for primary objective 2 will be: - Quality of life assessed using the Short Form 12 (SF-12) and the Mental health-Quality of Life (MH-QoL) questionnaires. - The levels of pain and fatigue as measured by the Numeric Rating Scale for Pain and Fatigue (NRS-PF). - Referral for psychological or psychiatric treatment, as measured by the results of the *Assessment of treatments received by the patient* at 12 months follow-up (T3). - Symptoms of depression, measured by the Patient Health Questionnaire-9 (PHQ-9) assessed at T0-T3. - Symptoms of anxiety, measured by the Generalized anxiety Disorder-7 (GAD-7) assessed at T0-T3. | — |
Countries
Netherlands
Outcome results
None listed