The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor

Melbourne Health30 enrolled

Overview

The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds of patients. Over half of the tremors involve the upper limb and frequently lead to further disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine, clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and tetrahydrocannabinol have been reported to have some beneficial effect but published evidence of effectiveness is very limited. The investigators' experience to date suggests that many of the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy. Aims: 1\. The investigators aim to determine the efficacy of commonly used doses of BOTOX on the patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects associated with this treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Multiple Sclerosis Tremor

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Relapsing-remitting MS or secondary progressive MS according to the Mc Donald criteria * Age 18-80 years of age * Competent to understand and sign informed consent * Presence of symptomatic head and/or limb tremor Exclusion Criteria: * Treatment with botulinum toxin type A of any brand within the 4 months prior to enrollment * A known contraindication to Botox injection * Pregnancy

Outcomes

Primary Outcomes

A decrease in tremor

Time frame: 6 months

Secondary Outcomes

The safety profile of Botulinum Toxin in MS patients