Botox as new treatment for unexplained jerky movement disorders.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR2478
• Date of registration: 24/08/2010
• Primary sponsor: Academic Medical Center (AMC)
• Public title: Botox as new treatment for unexplained jerky movement disorders.
• Scientific title: Botulinum neurotoxin as new treatment modality in jerky psychogenic movement disorders: a monocenter randomised controlled trial. -
• Date of first enrolment: 15/8/2010
• Target sample size: 54
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2478
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: Y.E.M. Dreissen

• Name: MAJ Koning-Tijssen, de

Key inclusion & exclusion criteria

Inclusion criteria: Patients with at least one invalidating consistent type of psychogenic jerk that is present for 1 year or longer.
Exclusion criteria: 1. Age < 18 years or > 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Botulinum neurotoxin (BoNT), Psychogenic jerky movement

Intervention(s)

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 period, all patients will receive 4 injections of BoNT also with 3 month intervals.

For individual patients, the dose of botulinum toxin to be injected will be determined based on the number and type of muscles that are involved in performing the jerk. The muscles that will be injected will be determined by a neurophysiologist experienced in treatment with BoNT according to the pattern of movements visible and according to the involved muscles measured with EMG. The dosage of BoNT depends on the volume of the muscle(s) it is injected in. Guidelines for starting dosages and for adjustments after the first injection for individual muscles exist. These guidelines will be used for the treatment of psychogenic jerks in this study. Because the dosage of BoNT depends on the muscles to be injected, individual patients will receive different dosages. The dilution volume of Dysport will be 500 units in 2.5 cc of 0.9% saline. The maximum dosage per treatment session is 400 Dysport units. BoNT is an accepted and widely-used therapy for dystonia and as such a great deal of experience is available.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

10/079

Source(s) of Monetary Support

Prinses Beatrix Fonds