To evaluate the effect of treatment with BoNT on psychogenic jerks.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure:
The improvement of motor characteristics of the jerk of interest assessed with
the Clinical Global Impression - Improvement scale by an independent movement
disorder specialist;
Secondary outcome
Secondary Objectives:
To asses, in patients with psychogenic jerks, the effect of treatment with BoNT
on:
* the severity of the invalidating jerk of interest scored by a movement
disorder specialist;
* improvement of motor characteristics and severity of the invalidating jerk of
interest scored by the patient;
* the nature, distribution and severity of overall dyskinesia, scored by a
movement disorder specialist;
* the frequency of the invalidating jerk of interest;
* whether patients consider treatment with BoNT effective and whether they
judge that the benefits of treatment outweigh the side-effects;
* disability;
* quality of life;
* co-existent psychiatric disorders;
* the occurrence of adverse reactions;
* muscle weakness.
Background summary
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 psychogenic movement disorders. These are disorders that
cannot be accounted for by a known neurologic syndrome. A substantial part of
these patients has jerks. Therapy of psychogenic jerks currently focuses on
frequently co-occurring psychiatric disease, but results are poor. In this
project, we will study the effect of BoNT on movement disorders of psychogenic
origin.
Study objective
To evaluate the effect of treatment with BoNT on psychogenic jerks.
Study design
We will perform a monocentre study. This study consists of two parts: a
double-blind randomized placebo controlled intervention study of 16 weeks and
an uncontrolled follow-up study of one year to evaluate the long-term effects
of BoNT.
Intervention
During the trial phase of the study, patients will receive up to two BoNT or
placebo injections. The number of muscles injected and the doses to be
administrated in an individual patient will be determined by an experienced
neurophysiologist analogous to treatment of dystonia. For the follow-up study,
all patients will be assigned to treatment with BoNT at intervals of
approximately 3 months until 12 months after the end of the trial period.
Study burden and risks
The risks associated with participation in this study are low: BoNT is
considered to be a safe therapy in other movement disorders. The most common
side effects of BoNT are local weakness and pain. These side effects are
reversible. The neuropsychological and psychiatric questionnaires used in our
study are considered to be mildly psychologically stressful.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
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. The jerk of interest has to significantly disable the patient in his/her daily functioning according to the patient and the movement disorder specialists and needs to be performed by a muscle or muscles amendable to injection. The jerk of interest may be simple or complex if only treatment with BoNT is considered possible.
Exclusion criteria
* Age < 18 years or > 80 years;
* Psychogenic jerk of interest present for < 1 year;
* Previous or current treatment with BoNT;
* Legally incompetent adult;
* Pregnancy;
* Coagulation disorders;
* Insufficient knowledge of Dutch language
* No informed consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-019338-29-NL |
| CCMO | NL32103.018.10 |