Session Information
Date: Thursday, June 8, 2017
Session Title: Clinical Trials and Therapy in Movement Disorders
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective: To demonstrate improvement of arm tremor severity and hand function with kinematics-guided inco/A therapy
Background: Botulinum neurotoxin A (BoNT-A) therapy of debilitating tremor symptoms could not show improvement of tremor severity and hand function without undesirable muscle weakness. In this study, we studied a new approach to BoNT-A tremor therapy using a diagnostic device, TremorTek™ kinematics-guided treatment support, for defining the inco/A injection protocol.
Methods: 19 essential tremor (ET) subjects received a single inco/A (Xeomin®) injection while 11 ET subjects received placebo. For each subject, an individualized set of muscles related to the pattern of wrist, elbow, and shoulder tremor was selected and the doses per muscle defined based on the TremorTek™ analysis. Total inco/A doses were <195U. Outcome parameters: Kinematics, clinical metrics like FTM, QUEST, Global Impression of Change, and grip strength were assessed over 24 weeks.
Results: Differences in change from baseline between the inco/A and placebo groups were assessed at weeks 4 and 8 for the maximum log-transformed accelerometric hand tremor amplitude and Fahn-Tolosa Marin Scale (FTM) Part B motor performance score. Inco/A treatment significantly improved wrist tremor amplitude vs. placebo at week 4 (95% CI [-1.21;-0.34] and at week 8 (95% CI [-0.95 ;-0.33]). Sensitivity analysis by ANCOVA: week 4 p=0.004, week 8 p<0.001. Motor performance scores of FTM Part B showed significantly higher improvement in the inco/A group vs. placebo at week 4 (95% CI [-3.4;-0.6]) and a trend towards higher improvement in the inco/A group at week 8 (95% CI [-2.9;0.4]). Sensitivity analysis by ANCOVA: week 4 p=0.003, week 8 p=0.031. TremorTek™ kinematic analysis results also showed persistent tremor effects up to 24 weeks after a single injection of inco/A. Max grip strength in the treated arm decreased by 20% with no notable change in the placebo group. 2 subjects reported localized finger muscle weakness.
Conclusions: Kinematics-guided inco/A therapy significantly decreased tremor severity and improved hand function vs. placebo. Despite the small sample size, hand accelerometry and FTM part B showed significant decrease in tremor severity and improvement in hand function. Individualized dosing was well tolerated. No premature discontinuation due to muscle weakness.
References: Brin MF, Lyons KE, Doucette J, et al. A randomized, double masked, controlled trial of botulinum toxin type A in essential hand tremor. Neurology. 2001;56(11):1523-8.
Samotus O, Rahimi F, Lee J, Jog M. Functional Ability Improved in Essential Tremor by IncobotulinumtoxinA Injections Using Kinematically Determined Biomechanical Patterns – A New Future. PLoS ONE. 2016;11(4):e0153739.
To cite this abstract in AMA style:
M. Jog, J. Lee, M. Althaus, A. Scheschonka, H. Dersch, E.T. Study Team, D. Simpson. Efficacy and safety of incobotulinumtoxinA (inco/A) for essential tremor using kinematics-guided clinical decision support: A randomized, double-blind, placebo-controlled trial [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/efficacy-and-safety-of-incobotulinumtoxina-incoa-for-essential-tremor-using-kinematics-guided-clinical-decision-support-a-randomized-double-blind-placebo-controlled-trial/. Accessed June 15, 2025.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-and-safety-of-incobotulinumtoxina-incoa-for-essential-tremor-using-kinematics-guided-clinical-decision-support-a-randomized-double-blind-placebo-controlled-trial/