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Botulinum toxin as a new treatment modality for jerky psychogenic movement disorders: a monocenter randomized controlled trial

Botulinum toxin as a new treatment modality for jerky psychogenic movement disorders: a monocenter randomized controlled trial - Botulinum neurotoxin as treatment in psychogenic jerks

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34213
Enrollment
54
Registered
2010-04-09
Start date
2011-01-27
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

conversion disorder functional movement disorder

Interventions

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 det

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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. 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

Exclusion criteria: * Age 80 years; * Psychogenic jerk of interest present for

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)