psychogenic movement disorder
Conditions
Interventions
2. 2 times injections of placebo intramuscular with a 3 month interval.
Placebo will consist of 0.9% sterile saline. This is a frequently used placebo in studies on botulinum toxin.
After the trial
Sponsors
Academic Medical Centre
Meibergdreef 9
1105 AZ Amsterdam
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Age 80 years; 2. Psychogenic jerk of interest present for < 1 year; 3. Previous or current treatment with BoNT; 4. Pregnancy; 5. Coagulation disorders; 6. Insufficient knowledge of Dutch language; 7. Legally incompetent adult; 8. No informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The effect of BoNT on: 1. The severity of jerks according to a movement disorder specialist; 2. Improvement and severity of the jerk according to the patient; 3. Nature and severity of overall dyskinesia; 4. Jerk frequency; 5. Whether patients consider treatment with BoNT effective; 6. Disability; 7. Quality of life; 8. Co-existent psychiatric disorders and the occurrence of adverse reactions; 9. Muscle weakness. | — |
Contacts
Public ContactMAJ Koning-Tijssen, de
Postbus 22660
Outcome results
None listed