Metacognitive Therapy and Neuro-physiotherapy as a Treatment for Functional Movement Disorders

NCT05323344 | Unknown DMC

• 1 other identifier: WE5919/4-1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with functional movement disorders (FMD) present with abnormal movements incompatible with symptoms of well-defined neurological disorders and are not associated with structural abnormality of the nervous system. FMD are very common. 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 is that there are no generally accepted therapeutic guidelines for FMD. Therefore, treatment strategies are urgently needed. Recent neurophysiological studies suggest common underlying disease mechanism across FMD patients, particularly abnormal allocation of attentional resources. Conceptually, this calls for therapeutic approaches, in which attention re-focusing is trained. In this respect, neuro-physiotherapy (NPT) is based on the physical movement retraining by demonstrating that normal movement is possible, to facilitate patients' confidence into the own movement capacity. Based on the current literature, the investigators suggest that NPT is a feasible and effective treatment options in FMD population. However, the proportion of patients fully accepting and improving from NPT was limited. FMD patients might be more receptive to NPT if additional specialized psychotherapy approaches, e.g., metacognitive therapy (MCT) is offered. MCT focusses on patients believes about their own mind and cognition (metacognition). It explains how dysfunctional patterns of thinking and self-awareness can lead to and maintain FMD and in particular trains patients to consciously (re-)focus their attention away from unpleasant or disturbing mental processes. Thus, the investigators aim to analyze, in addition to NPT only, the feasibility and treatment efficacy of a combination of NPT and MCT. The investigators will apply therapy frequently (2 times 1 hour sessions per week over 10 weeks) and patients will be instructed for an additional home-based training. Effectiveness will be analyzed up to 12 month after the intervention by validated, FMD-specific, blinded video ratings. Importantly, FMD patients have been shown to have the potential for a full recovery if sufficient treatment is applied. Therefore, the therapeutic approaches of the clinical feasibility trial, if successful, are expected to have immediate and strong impact on the care of FMD patients including an improvement in quality of life, and to reduce health care system burdens.

Conditions

Conversion Disorder

Keywords

functional movement disorders; feasibility study; Physiotherapy; Metacognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Changes in Score on the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) between baseline and up to one week after intervention

  Clinician-rated, rating scale for functional motor symptoms; used for blinded video rating

  baseline, up to 1 week after intervention, 3, 6, and 12 month follow-up

Secondary Outcomes (18)

• Changes in Score on the Psychogenic movement disorders rating scale (PMDRS)

  baseline, up to 1 week after intervention, 3, 6, and 12 month follow-up

• Changes in Score on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I)

  baseline, up to 1 week after intervention, 3, 6, and 12 month follow-up

• Changes in Score on the Clinical Global Impression (CGI)

  baseline, up to 1 week after intervention, 3, 6, and 12 month follow-up

• Changes in Score on the Short Form Health Survey-36 (SF-36)

  baseline, up to 1 week after intervention, 3, 6, and 12 month follow-up

• Changes in Score on the Fatigue Assessment Scale

  baseline, up to 1 week after intervention, 3, 6, and 12 month follow-up

Other Outcomes (6)

• Transcranial magnetic stimulation

  baseline, up to 1 week after intervention, 3, 6, and 12 month follow-up

• Magnetic resonance imaging (DTI)

  baseline, 3, 12 month follow-up

• Magnetic resonance imaging (Resting State)

  baseline, 3, 12 month follow-up

Study Arms (2)

Neuro-physiotherapy

ACTIVE COMPARATOR

In intervention group I, patients will receive a one hour session of special Neuro-physiotherapy (NPT) twice per week with a total of 20 sessions over 10 weeks. In addition, patients will be instructed to a home-based training, so that they continue their training in between sessions and after completion of the 10 weeks intervention. NPT is designed to target the abnormal movements. It is based on previously established consensus recommendations and feasibility for a short (5 days) intervention was already tested. Adapted from Nielsen et al., each of our NPT sessions will include patient education, movement retraining and development of a self-management plan.

Other: Neuro-physiotherapy

Combination of metacognitive therapy and Neuro-physiotherapy

ACTIVE COMPARATOR

In intervention group II, patients will be treated for 10 weeks by a combination of Metacognitive behavioral therapy (MCT) and Neuro-physiotherapy (NPT) (1 hour MCT and 1 hour NPT per week with a total of 20 treatment sessions over 10 weeks). The key feature during MCT sessions will be based on an attention training technique (ATT), which prevents or interrupts self-focused attention and reduces the overall level of preoccupation with the FMD. Patients will receive at least three competing sounds. Patients will be asked to practice the training with their eyes open and focused on a visual fixation point. Patients' self-reliance will be strengthened by an individualized cognitive self-training explained and practiced with the MCT therapist including an audio tape of the ATT training. This should be continued daily at home in between sessions and after completion of the 10 weeks intervention. Self-training will be documented in a daily training diary.

Other: Combination of metacognitive behavioral therapy and Neuro-physiotherapy

Interventions

Neuro-physiotherapy OTHER

Neuro-Physiotherapy will be done in Intervention group I

Neuro-physiotherapy

Combination of metacognitive behavioral therapy and Neuro-physiotherapy OTHER

Combination of metacognitive behavioral therapy and Neuro-physiotherapy will be done in intervention group II

Combination of metacognitive therapy and Neuro-physiotherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically established diagnosis of functional movement disorders (FMD) according to the revised Fahn-Williams criteria. Patients with FMD with different phenomenology, i.e. patients with functional myoclonus, dystonia, tremor and functional gait disorders will be included to guarantee generalizability and representativeness of this heterogeneous disorder.

You may not qualify if:

• Significant major neuropsychiatric/neurological disorder
• medical illness with known central nervous system consequences,
• acute unstable psychiatric diseases,
• pain disorders,
• paroxysmal FMD,
• isolated functional paresis,
• inability to read and speak German,
• age \< 18 years. Children with FMD are excluded because they would require age-adjusted assessment and tailored treatment in a specialized neuropediatric unit.

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (2)

Department of Neurology, University Clinic Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

RECRUITING

Institute of Systems Motor Science, University Clinic Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23562, Germany

RECRUITING

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Anne Weissbach, MD

  Institute of Systems Motor Science, University Clinic of Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Weissbach, MD

CONTACT

0049(0)45131018219; anne.weissbach@neuro.uni-luebeck.de

Kirsten Zeuner, MD

CONTACT

k.zeuner@neuro.uni-kiel.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded video rating for primary endpoint
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Feasibility study

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 12, 2022
• Study Start: May 20, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)