Botulinum Neurotoxin (BoNT) as new treatment for functional (psychogenic) jerky movement disorders.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26050

Enrollment

Registered

2010-08-24

Start date

2011-03-07

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Botulinum neurotoxin (BoNT) has emerged as a useful therapy for several movement disorders associated with muscle overactivity such as dystonia and jerky movement disorders. At least 2–9% of patients seen in movement disorder clinics suffer from movement disorders with a psychogenic origin and a substantial part of them has jerks. These psychogenic jerky movement disorders cannot be accounted for by a known neurologic syndrome.

Interventions

Patients will be randomized to treatment with: 1. 2 times injections with botulinum neurotoxin injections intramuscular with a 3 month interval, or

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

Eligibility

Inclusion criteria

Inclusion criteria: Patients with at least one invalidating consistent type of psychogenic jerk that is present for 1 year or longer. Patients with one consistent type of invalidating tremor present for one year or longer .

Exclusion criteria

Exclusion criteria: 1. Age 80 years; 2. Psychogenic jerk of interest present for < 1 year; 3. Treated with BoNT two or more times in the past year; 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; 9. The occurrence of adverse reactions; 10. Muscle weakness.	—

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; 9. The occurrence of adverse reactions; 10. Muscle weakness.

—

Contacts

Public ContactY.E.M. Dreissen

PO Box 22660

y.e.dreissen@amc.uva.nl+31 (0)20 5668417

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)