Abstract Details

Title Safety and Efficacy of a Wrist-worn Vibratory Stimulation Wearable for Upper Limb Tremor Reduction in Essential Tremor (ULTRE): A Randomized, Controlled Trial

Topic Movement Disorders

Presentation(s) S37 - Movement Disorders: Clinical Trials (1:12 PM-1:24 PM)

Poster/Presentation
Number 002

Background ET is a prevalent movement disorder characterized primarily by upper limb tremor. Most patients respond inadequately to existing treatments. The wrist-worn device delivers targeted vibrotactile stimulation to reduce tremor severity.

Objective To evaluate the safety, tolerability, and efficacy of a wrist-worn vibratory stimulation wearable from Encora Therapeutics for Upper Limb Tremor Reduction in Essential Tremor (ULTRE) by comparing two vibrotactile stimulation paradigms against an inactive sham in patients with essential tremor (ET).

Design/Methods The ULTRE study is a prospective, double-blind, randomized, sham-controlled, cross-over clinical trial. Pulsed (low-amplitude stimulation at 0.125Hz) and Continuous (high-amplitude stimulation at the tremor frequency) paradigms were compared with inactive Sham. Subjects with tremor severity ≥2 in one upper limb Essential Tremor Rating Assessment Scale task (TETRAS items 4, 6, and 8) and ≥3 in one Bain & Findley Activities of Daily Living task (BF-ADL items 2, 4, 17, and 22) were randomized 1:1:1. TETRAS and BF-ADL tasks performed before (Baseline), during, and after stimulation were both self rated (BF-ADL) and evaluated by blinded experienced video raters (TETRAS). Primary endpoints were tolerability and adverse events (AEs). Secondary endpoints were changes in BF-ADL (4 tasks; scores: 4-16) and TETRAS (5 tasks; scores: 0-20) composite scores.

Results Mild-to-moderate, non-serious device-related AEs occurred in 5.6% of participants, all resolving without intervention; and 94% rated the device as comfortable. Both stimulation patterns resulted in statistically significant (p<0.05) improvements vs. baseline in BF-ADL (Pulsed: 1.93±0.56; Continuous: 1.32±0.57) and TETRAS (Pulsed: 1.40±0.60; Continuous: 0.62±0.56). Pulsed outperformed Sham in both BF-ADL and TETRAS (p<0.01), and Continuous outperformed Sham in BF-ADL (p<0.05). There appeared to be a cumulative benefit over the treatment period.

Conclusions The Encora Device was safe and well-tolerated. Both stimulation patterns produced statistically significant improvements compared to Baseline and Sham. A beneficial response to Pulsed stimulation was unexpected, and the optimum stimulation pattern requires further study.

Authors/Disclosures
Fatta B. Nahab, MD, FAAN (UCSD) PRESENTER	Dr. Nahab has received personal compensation for serving as an employee of Neuron23. Dr. Nahab has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Encora. Dr. Nahab has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ActualSignal. Dr. Nahab has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Attune Neurosciences, Inc.. Dr. Nahab has stock in Biogen. Dr. Nahab has received personal compensation in the range of $500-$4,999 for serving as a DSMB Member with NIH.
Daniel Carballo, Other (Encora Therapeutics)	Mr. Carballo has received personal compensation for serving as an employee of Encora Therapeutics. Mr. Carballo has stock in Encora Therapeutics.
Allison Davanzo (Encora Therapeutics)	Ms. Davanzo has received personal compensation for serving as an employee of Encora Therapeutics. Ms. Davanzo has stock in Encora Therapeutics.
Kristi Winterfeldt	Ms. Winterfeldt has received personal compensation for serving as an employee of Encora Therapeutics.
Srikar Nekkanti	Mr. Nekkanti has nothing to disclose.
Han B. Kim, MSE	Mr. Kim has received personal compensation for serving as an employee of Encora Therapeutics.
Ludy C. Shih, MD, FAAN (Beth Israel Deaconess Medical Center)	Dr. Shih has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Encora Therapeutics. Dr. Shih has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for WCG Medavante. Dr. Shih has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Ventyx Biosciences. Dr. Shih has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspen Neuroscience. Dr. Shih has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Shih has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Wiley. The institution of Dr. Shih has received research support from Praxis Precision Medicines. The institution of Dr. Shih has received research support from Tremor Research Group. The institution of Dr. Shih has received research support from Denali Therapeutics. The institution of Dr. Shih has received research support from University of Rochester. Dr. Shih has received personal compensation in the range of $500-$4,999 for serving as a Consultant with German Accelerator. Dr. Shih has received personal compensation in the range of $500-$4,999 for serving as a Grant Reviewer with National Institutes of Health. Dr. Shih has received personal compensation in the range of $500-$4,999 for serving as a Grant Reviewer with Michael J. Fox Foundation. Dr. Shih has received personal compensation in the range of $500-$4,999 for serving as a Grant Reviewer with Johns Hopkins. Dr. Shih has a non-compensated relationship as a Co-chair, Scientific Program Committee and President-Elect with American Society of Experimental Neurotherapeutics that is relevant to AAN interests or activities.
Rodger J. Elble, MD, PhD, FAAN (Southern IL Univ Sch of Med)	Dr. Elble has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz. Dr. Elble has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage . Dr. Elble has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ES Therapeutics. Dr. Elble has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Applied Therapeutics. Dr. Elble has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Praxis.

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