Botuline toxine als nieuwe behandeling voor onverklaarde schokken.

Conditions: psychogenic movement disorder

Registration Number: NL-OMON28532

Lead Sponsor: Academic Medical CentreMeibergdreef 91105 AZ Amsterdam

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 54

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. To be included, patients need to experience to be significantly impaired in daily functioning due to one specific jerk. The jerk of interest needs to be performed by a muscle or muscles amendable to injection and may be simple or complex if only treatment with BoNT is considered possible. No change in medication in the month prior to participation is allowed.

Exclusion Criteria

1. Age < 18 years or > 80 years;

2. Psychogenic jerk of interest present for < 1 year;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess whether treatment with BoNT leads to improvement of psychogenic jerks according to an independent movement disorder specialist assessed with the Clinical Global Impression - Improvement scale.

Secondary Outcome Measures

Name	Time	Method
The effect of BoNT on:<br /><br>1. The severity of jerks according to a movement disorder specialist;<br /><br>2. Improvement and severity of the jerk according to the patient;<br /><br>3. Nature and severity of overall dyskinesia;<br /><br>4. Jerk frequency;<br /><br>5. Whether patients consider treatment with BoNT effective;<br /><br>6. Disability;<br /><br>7. Quality of life;<br /><br>8. Co-existent psychiatric disorders and the occurrence of adverse reactions;<br /><br>9. Muscle weakness.