|- candidate number||8767|
|- NTR Number||NTR2660|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-dec-2010|
|- Secondary IDs||10/079 METC AMC |
|- Public Title||Botuline toxine als nieuwe behandeling voor onverklaarde schokken.|
|- Scientific Title||Botulinum neurotoxin as new treatment modality in jerky psychogenic movement disorders: A randomized controlled trial.|
|- hypothesis||BonT is an effective treatment for psychogenic movement disorders.|
|- Healt Condition(s) or Problem(s) studied||Psychogenic movement disorder|
|- 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;
3. Previous or current treatment with BoNT;
5. Coagulation disorders;
6. Insufficient knowledge of Dutch language;
7. Legally incompetent adult;
8. No informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||1-sep-2014|
|- Target number of participants||54|
|- 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 period, all patients will receive 4 injections of BoNT also with 3 month intervals.
|- Primary outcome||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||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;
7. Quality of life;
8. Co-existent psychiatric disorders and the occurrence of adverse reactions;
9. Muscle weakness.
t= 16 weeks;
t= 16 months.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. MAJ Koning-Tijssen, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. MAJ Koning-Tijssen, de|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Prinses Beatrix Fonds|
|- Brief summary||Background:|
Botulinum neurotoxin (BoNT) has emerged as a useful therapy for several hyperkinetic movement disorders, especially dystonia. Previous research and our own clinical experience suggest that treatment with BoNT is an effective therapy for jerky movements as well. In this project, we will study the effect of BoNT on psychogenic jerky movement disorders.
Psychogenic movement disorders cannot be accounted for by a known neurologic syndrome. At least 2–9% of patients seen in movement disorder clinics suffer from psychogenic movement disorders and a substantial part has jerks. Therapy currently focuses on frequently co-occurring psychiatric disease, but results are poor. Because evidence that the distinction between organic and psychogenic disease is not clear cut is increasing, other treatment options are considered for psychogenic movement disorders.
Administration of BoNT is an effective treatment for psychogenic jerks that significantly compromise patients.
We will study the effect of BoNT on psychogenic jerks by assessing:
1. Improvement in jerk severity assessed with the Clinical Global Impression - Improvement scale (primary outcome measure);
2. Jerk frequency;
3. Whether patients consider treatment with BoNT effective;
4. Disability and daily functioning;
5. Co-existent psychiatric disorders.
Materials and methods:
A phase II single-center double blind randomized placebo-controlled trial will be performed. We will include 31 patients with at least one disabling psychogenic jerk in each treatment arm. Patients will be injected with BoNT up to two times during the trial. Assessments will be performed in week 4, 8 and 12 and will include standardized scales, counts of the jerk of interest on video and registration of the jerk using an actograph. The effect of BoNT after 1 year of treatment will be evaluated subsequently.
This study will provide evidence on a promising new therapeutic option for psychogenic jerks, a prevalent movement disorders for which results of current therapies are poor.
|- Main changes (audit trail)||14-aug-2014: Double registration: see trialregistration NTR 2478 - AB|
|- RECORD||13-dec-2010 - 15-aug-2014|