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

Publication ,  Journal Article
Isaacson, SH; Peckham, E; Tse, W; Waln, O; Way, C; Petrossian, MT; Dahodwala, N; Soileau, MJ; Lew, M; Dietiker, C; Luthra, N; Agarwal, P ...
Published in: Tremor Other Hyperkinet Mov (N Y)
August 14, 2020

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.

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Published In

Tremor Other Hyperkinet Mov (N Y)

DOI

EISSN

2160-8288

Publication Date

August 14, 2020

Volume

10

Start / End Page

29

Location

England

Related Subject Headings

  • Young Adult
  • Radial Nerve
  • Prospective Studies
  • Outcome Assessment, Health Care
  • Middle Aged
  • Median Nerve
  • Male
  • Humans
  • Hand
  • Female
 

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Isaacson, S. H., Peckham, E., Tse, W., Waln, O., Way, C., Petrossian, M. T., … Pahwa, R. (2020). Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor. Tremor Other Hyperkinet Mov (N Y), 10, 29. https://doi.org/10.5334/tohm.59
Isaacson, Stuart H., Elizabeth Peckham, Winona Tse, Olga Waln, Christopher Way, Melita T. Petrossian, Nabila Dahodwala, et al. “Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor.Tremor Other Hyperkinet Mov (N Y) 10 (August 14, 2020): 29. https://doi.org/10.5334/tohm.59.
Isaacson SH, Peckham E, Tse W, Waln O, Way C, Petrossian MT, et al. Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor. Tremor Other Hyperkinet Mov (N Y). 2020 Aug 14;10:29.
Isaacson, Stuart H., et al. “Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor.Tremor Other Hyperkinet Mov (N Y), vol. 10, Aug. 2020, p. 29. Pubmed, doi:10.5334/tohm.59.
Isaacson SH, Peckham E, Tse W, Waln O, Way C, Petrossian MT, Dahodwala N, Soileau MJ, Lew M, Dietiker C, Luthra N, Agarwal P, Dhall R, Morgan J, Calakos N, Zesiewicz TA, Shamim EA, Kumar R, LeWitt P, Shill HA, Simmons A, Pagan FL, Khemani P, Tate J, Maddux B, Luo L, Ondo W, Hallett M, Rajagopal A, Chidester P, Rosenbluth KH, Delp SL, Pahwa R. Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor. Tremor Other Hyperkinet Mov (N Y). 2020 Aug 14;10:29.

Published In

Tremor Other Hyperkinet Mov (N Y)

DOI

EISSN

2160-8288

Publication Date

August 14, 2020

Volume

10

Start / End Page

29

Location

England

Related Subject Headings

  • Young Adult
  • Radial Nerve
  • Prospective Studies
  • Outcome Assessment, Health Care
  • Middle Aged
  • Median Nerve
  • Male
  • Humans
  • Hand
  • Female