Metacognitive Therapy and Neuro-physiotherapy as a Treatment for Functional Movement Disorders - a Randomized, Observer-blinded Feasibility Trial

Trial Design The proposed clinical feasibility pilot study contains two intervention groups. Patients with functional movement disorders (FMD) will be randomized into the two groups. Patients of the intervention group I will receive 10 weeks neuro-physiotherapy (NPT) and patients of the intervention group II a combination of NPT and metacognitive therapy (MCT).

Frequency and Scope of Trial Visits At a screening visit before participation in the clinical trial all patients will be assessed for eligibility by applying the inclusion and exclusion criteria and will be provided with information to obtain informed consent. If eligible, patients are randomized to the two different groups. At baseline examination, social demographic information (age, gender, education, family status etc.) and medical history (age at onset, disease duration, potential triggers, comorbidities, previous therapies etc.) are obtained. At baseline, immediately after completion of the intervention and at three, six and 12 months follow-up visits the investigators will use a standardized video protocol that ensures consistent examination of the movement disorder according to a standardized video-guided instruction protocol. It allows a blinded, objective video rating of patients' symptoms at all five study visits by the investigators that will stay blinded to the treatment status of the patient. Both have extensive experience in design, conduction and analysis of movement disorders video ratings. They will rate the severity of symptoms by applying clinical rating scales and questionnaires for patients with functional movement disorders. The baseline visit will take two hours and the post-interventional as well as follow-up visits will each last one hour.

Medical Problem and Relevance Patients with FMD present with different abnormal movements such as functional tremor, dystonia, myoclonus, or gait disorders and often also other symptoms and signs suggesting the involvement of the nervous system. FMD are incompatible with symptoms and signs of well-defined neurological disorders and are not associated with structural abnormality of the nervous system. Importantly, FMD disorders can reliably be diagnosed clinically on the basis of characteristic signs including incongruency of symptoms regarding anatomy and physiology, variable phenomenology, attention dependency, i.e. increased distractibility, entrainment and other specific signs, for instance, Hoover's sign. Thus, FMD is not a diagnosis of exclusion. Although FMD were referred to as "psychogenic" or "conversion movement disorder" suggesting psychopathology as a pre-requisite, a high percentage of patients in fact do not have psychiatric comorbidities.

The level of distress, disability and chronification of symptoms in patients with FMD is comparable to or even higher than that in patients with defined neurological disorders. FMDs are very common and along with other disorders in the spectrum of functional neurological disorders (FND), account for up to one-third of new referrals seen in neurology clinics. Their prevalence in private neurological practices is about 16% and almost as high as patients with headaches (19%) or epilepsy (14%). FMDs account for up to 20% of patients seen in movement disorders clinics. However, the pattern of care of these patients is highly inconsistent and most patients feel dissatisfied with the treatment they receive.

One reason for this unsatisfactory scenario that is also severely affecting the German healthcare system, is that there are no generally accepted therapeutic guidelines for FND patients. Often, patients are referred from one specialist to the other with neither neurologist nor psychiatrist taking on the long-term care for these patients due to a lack of validated treatment strategies. Patients typically seek advice from different specialists and often receive unnecessary, cost intensive diagnostic procedures that might be associated with complications. This leads to further referrals, unnecessary use of valuable health care system resources and secondary iatrogenic morbidity. The Scottish Neurological Symptom Study showed that patients suffering from FND create direct health care cost of about £11.3 million per year in Scotland. A study from the USA estimated the direct healthcare cost of FND patients in the USA of about $256 billion. In comparison to other neurological disorders, FND patients demand not only significantly more primary, specialty and emergency care visits, but also in- and outpatient clinic administrations.