Botulinum toxin as a new treatment modality for jerky psychogenic movement disorders: a monocenter randomized controlled trial

Phase 2

Completed

Conditions: conversion disorder
functional movement disorder
10028037

Registration Number: NL-OMON34213

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Eligible patients for the study have at least one consistent type of jerk of psychogenic origin. Two movement disorder specialists have to agree on the diagnosis based on clinical characteristics and on additional investigations if considered necessary. The diagnosis of psychogenic jerks needs to have a *definite* or *probable* level of certainty for psychogenic movement disorders. The jerk of interest has to significantly disable the patient in his/her daily functioning according to the patient and the movement disorder specialists and needs to be performed by a muscle or muscles amendable to injection. The jerk of interest may be simple or complex if only treatment with BoNT is considered possible.

Exclusion Criteria

* Age < 18 years or > 80 years;
* Psychogenic jerk of interest present for < 1 year;
* Previous or current treatment with BoNT;
* Legally incompetent adult;
* Pregnancy;
* Coagulation disorders;
* Insufficient knowledge of Dutch language
* No informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure:<br /><br>The improvement of motor characteristics of the jerk of interest assessed with<br /><br>the Clinical Global Impression - Improvement scale by an independent movement<br /><br>disorder specialist; </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives:<br /><br>To asses, in patients with psychogenic jerks, the effect of treatment with BoNT<br /><br>on:<br /><br>* the severity of the invalidating jerk of interest scored by a movement<br /><br>disorder specialist;<br /><br>* improvement of motor characteristics and severity of the invalidating jerk of<br /><br>interest scored by the patient;<br /><br>* the nature, distribution and severity of overall dyskinesia, scored by a<br /><br>movement disorder specialist;<br /><br>* the frequency of the invalidating jerk of interest;<br /><br>* whether patients consider treatment with BoNT effective and whether they<br /><br>judge that the benefits of treatment outweigh the side-effects;<br /><br>* disability;<br /><br>* quality of life;<br /><br>* co-existent psychiatric disorders;<br /><br>* the occurrence of adverse reactions;<br /><br>* muscle weakness.</p><br>