Abstract
HighlightsThis 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.
Highlights
Essential tremor (ET) is one of the most common movement disorders [1]
For patients who do not respond to medications, current alternative options are invasive neurosurgical procedures, including ventral intermediate nucleus (VIM) deep brain stimulation (DBS), or magnetic resonance-guided focused ultrasound (MRgFUS) VIM thalamotomy [17, 23]
This study suggested that Transcutaneous Afferent Patterned Stimulation (TAPS) therapy provided repeatable therapeutic benefit with a favorable safety profile over three months of use in adults with ET
Summary
Essential tremor (ET) is one of the most common movement disorders [1]. Upper limbs are affected in virtually all ET patients, and other regions (e.g., head, voice, and lower limbs) are affected in some patients [2, 3]. For patients who do not respond to medications, current alternative options are invasive neurosurgical procedures, including VIM deep brain stimulation (DBS), or magnetic resonance-guided focused ultrasound (MRgFUS) VIM thalamotomy [17, 23]. These second-line options, while effective for many, carry the significant safety risks and expenses associated with invasive procedures [24, 25]
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