Botulinum toxin injections for upper limb tremor

Not Applicable

Recruiting

• Conditions: Tremor; Upper limb proximal dystonic tremor; Parkinson's disease tremor; lesional tremor; Neurological - Parkinson's disease; Neurological - Other neurological disorders

• Registration Number: ACTRN12619000157178
• Lead Sponsor: health western sydney local health district

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-04
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients will be selected on the basis of upper limb tremor at the shoulder and/or elbow joint either during action, determined by finger-to-nose task and/or posturing with arms outstretch or in the targeting-nose position.

Exclusion Criteria

1.Patient treated with BoNTA within 6 months before evaluation
2.Changes in any medications that might affect the severity of tremor within 3 months before enrolling or during the 6 months of evaluation.
3.Inability to comply with the study requirements and follow-up period.
4.Patients with cognitive impairment who is unable to complete the assessment
5.Patients in whom consent is unable to be obtained from themselves or next of kin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Goal Attainment Rating Scale[4, 8, 12. 16, 20, 24, 28 and 32 weeks after the Baseline visit. The primary timepoint will be either week 4 or 8 (4-8 weeks post-injection 1), or week 20 or 24 (4-8 weeks post-injection 2), whichever shows the greater improvement in GAS ]

Secondary Outcome Measures

Name	Time	Method
1. Canadian Occupational Performance score<br>[4, 8, 12. 16, 20, 24, 28 and 32 weeks after the Baseline visit. ];2. Bain and Findley Tremor ADL Scale total score <br>[4, 8, 12. 16, 20, 24, 28 and 32 weeks after the Baseline visit. ];3. Quality of Life in Essential Tremor Questionnaire (QUEST scoring)<br>[4, 8, 12. 16, 20, 24, 28 and 32 weeks after the Baseline visit. ];4. Fahn, Tolosa, Martin Tremor Rating Scale <br><br>[4, 8, 12. 16, 20, 24, 28 and 32 weeks after the Baseline visit. ];5. The Essential Tremor Rating Assessment Scale <br>[4, 8, 12. 16, 20, 24, 28 and 32 weeks after the Baseline visit. ];6 Global rating scale <br>[4, 8, 12. 16, 20, 24, 28 and 32 weeks after the Baseline visit. ];7 Amplitude of the accelerometry and surface EMG[4, 8, 12. 16, 20, 24, 28 and 32 weeks after the Baseline visit. ]