Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor
| Autor: | Nicole Calakos, Lan Luo, Rohit Dhall, Holly A. Shill, Olga Waln, Paula Chidester, Mark Hallett, Michael J. Soileau, Adam Simmons, Brian N. Maddux, Peter A LeWitt, Rajesh Pahwa, Nijee Luthra, Melita T. Petrossian, Rajeev Kumar, John C. Morgan, Pravin Khemani, Cameron Dietiker, Christopher Way, Kathryn H. Rosenbluth, Ejaz A. Shamim, Scott L. Delp, Stuart Isaacson, Fernando Pagan, Apoorva Rajagopal, Mark F. Lew, Nabila Dahodwala, Theresa A. Zesiewicz, William G. Ondo, Jessica Tate, Elizabeth Peckham, Winona Tse, Pinky Agarwal |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty Activities of daily living Essential Tremor non-invasive Electric Stimulation Therapy Wrist stimulation Article Young Adult Quality of life Outcome Assessment Health Care medicine Humans Prospective Studies Adverse effect Prospective cohort study Aged Aged 80 and over clinical trials Essential tremor business.industry Middle Aged medicine.disease Hand tremor Neuromodulation (medicine) Median Nerve Clinical trial medicine.anatomical_structure neuromodulation Physical therapy Female Radial Nerve business |
| Zdroj: | Tremor and Other Hyperkinetic Movements |
| ISSN: | 2160-8288 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|