This study is investigating the impact of onabotulinum toxin A (Botox) injection on rest tremors in patients with Parkinson’s disease. The main outcome to be measured is the change in tremor symptoms before and after treatment. This study is recruiting in Chapel Hill, North Carolina.
The details
Rest tremors are often difficult to treat using typical Parkinson’s medications. Currently only deep brain stimulation is predictably effective, but this involves an invasive surgical procedure. Onabotulinum toxin A is a toxin that can paralyze the muscle it is injected into.
This study is investigating if tremors can be significantly improved with onabotulinum toxin injection. The main outcomes to be measured will be change in tremor symptoms, as well as change in tremor intensity and hand and arm function.
Who are they looking for?
This study is recruiting up to 16 patients experiencing rest tremors of one or both upper limbs. Rest tremors must be refractory (did not respond to treatment) to at least 2 lines of Parkinson’s disease medications. Patients must not change their medications for the entire study (150 days).
Patients with a history of onabotulinum toxin injections or deep brain stimulation surgery for any conditions cannot participate. Patients allergic to levodopa or carbidopa cannot participate. Patients with neuromuscular disorders or poor lung function cannot participate. Any female participants cannot be pregnant.
How will it work
In the first session, patients will be given either onabotulinum toxin injection (treatment) or placebo (substance with no active effect). After 3 months, patients who received onabotulinum toxin injection will receive placebo, and vice versa.
Tremor symptoms are evaluated using the Unified Parkinson’s Disease Rating Scale. Tremor severity is measured using a camera system that records the tremors. Improvement in limb function is also evaluated. All outcomes are measured before treatment and 1 month after treatment.
