Dataset Information

Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor.

ABSTRACT:

Highlights

This prospective study is one of the largest clinical trials in essential tremor to date. Study findings suggest that individualized non-invasive neuromodulation therapy used repeatedly at home over three months results in safe and effective hand tremor reduction and improves quality of life for many essential tremor patients.

Background

Two previous randomized, controlled, single-session trials demonstrated efficacy of non-invasive neuromodulation therapy targeting the median and radial nerves for reducing hand tremor. This current study evaluated efficacy and safety of the therapy over three months of repeated home use.

Methods

This was a prospective, open-label, post-clearance, single-arm study with 263 patients enrolled across 26 sites. Patients were instructed to use the therapy twice daily for three months. Pre-specified co-primary endpoints were improvements on clinician-rated Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) and patient-rated Bain & Findley Activities of Daily Living (BF-ADL) dominant hand scores. Other endpoints included improvement in the tremor power detected by an accelerometer on the therapeutic device, Clinical and Patient Global Impression scores (CGI-I, PGI-I), and Quality of Life in Essential Tremor (QUEST) survey.

Results

205 patients completed the study. The co-primary endpoints were met (p?0.0001), with 62% (TETRAS) and 68% (BF-ADL) of 'severe' or 'moderate' patients improving to 'mild' or 'slight'. Clinicians (CGI-I) reported improvement in 68% of patients, 60% (PGI-I) of patients reported improvement, and QUEST improved (p = 0.0019). Wrist-worn accelerometer recordings before and after 21,806 therapy sessions showed that 92% of patients improved, and 54% of patients experienced ?50% improvement in tremor power. Device-related adverse events (e.g., wrist discomfort, skin irritation, pain) occurred in 18% of patients. No device-related serious adverse events were reported.

Discussion

This study suggests that non-invasive neuromodulation therapy used repeatedly at home over three months results in safe and effective hand tremor reduction in many essential tremor patients.

SUBMITTER: Isaacson SH

PROVIDER: S-EPMC7427656 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Publications

Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor.

Isaacson Stuart H SH Peckham Elizabeth E Tse Winona W Waln Olga O Way Christopher C Petrossian Melita T MT Dahodwala Nabila N Soileau Michael J MJ Lew Mark M Dietiker Cameron C Luthra Nijee N Agarwal Pinky P Dhall Rohit R Morgan John J Calakos Nicole N Zesiewicz Theresa A TA Shamim Ejaz A EA Kumar Rajeev R LeWitt Peter P Shill Holly A HA Simmons Adam A Pagan Fernando L FL Khemani Pravin P Tate Jessica J Maddux Brian B Luo Lan L Ondo William W Hallett Mark M Rajagopal Apoorva A Chidester Paula P Rosenbluth Kathryn H KH Delp Scott L SL Pahwa Rajesh R

Tremor and other hyperkinetic movements (New York, N.Y.) 20200814

<h4>Highlights</h4>This prospective study is one of the largest clinical trials in essential tremor to date. Study findings suggest that individualized non-invasive neuromodulation therapy used repeatedly at home over three months results in safe and effective hand tremor reduction and improves quality of life for many essential tremor patients.<h4>Background</h4>Two previous randomized, controlled, single-session trials demonstrated efficacy of non-invasive neuromodulation therapy targeting the ...[more]

PMID: 32864188

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Dataset Information

Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor.

Highlights

Background

Methods

Results

Discussion

Publications

Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor.

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