Evaluation of Botulinum Toxin Injection Efficacy in the Treatment of Head Essential Tremor
Status:
Unknown status
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
Essential head tremor (HT) does not usually respond to drug treatment such as propranolol or
primidone or to surgical treatment such as deep brain stimulation of the thalamic ventralis
intermedius nucleus. Botulinum toxin (Btx) is widely used and efficient in the treatment of
blepharospasm and cervical dystonia. Btx prevents the release of acetylcholine in synapses,
leading to a reduction of pathological muscle movement. Very little information is available
on its efficacy on HT. Two published reports suggested that local Btx A injections could be
an effective and safe approach for treating HT. Given the scarcity of published data (small
samples, open studies, different doses of Btx used, heterogeneous populations, several
muscles injected, etc.), the aim of this study is to demonstrate the efficacy of Btx
injections in essential HT by a multi-center, randomized, double-blind, parallel-group,
placebo-controlled study.
Principal objective: To evaluate the efficacy of botulinum toxin injections in the treatment
of head tremor.
Secondary objectives:
- - To evaluate the tolerance of botulinum toxin injections in the treatment of head
tremor.
- - To evaluate the impact of botulinum toxin injections on the patients' quality of life
and embarrassment.
- To evaluate the changes of tremor characteristics induced by a Btx treatment using a 3D
accelerometer wireless portable system (Xsens MTw wireless motion tracker system)
(tremor frequency, tremor displacement, mean peak amplitude, distance traveled) and a
new video system device to analyze head tremor characteristics