TY - JOUR
T1 - Prospective home-use study on non-invasive neuromodulation therapy for essential tremor
AU - Isaacson, Stuart H.
AU - Peckham, Elizabeth
AU - Tse, Winona
AU - Waln, Olga
AU - Way, Christopher
AU - Petrossian, Melita T.
AU - Dahodwala, Nabila
AU - Soileau, Michael J.
AU - Lew, Mark
AU - Dietiker, Cameron
AU - Luthra, Nijee
AU - Agarwal, Pinky
AU - Dhall, Rohit
AU - Morgan, John
AU - Calakos, Nicole
AU - Zesiewicz, Theresa A.
AU - Shamim, Ejaz A.
AU - Kumar, Rajeev
AU - Lewitt, Peter
AU - Shill, Holly A.
AU - Simmons, Adam
AU - Pagan, Fernando L.
AU - Khemani, Pravin
AU - Tate, Jessica
AU - Maddux, Brian
AU - Luo, Lan
AU - Ondo, William
AU - Hallett, Mark
AU - Rajagopal, Apoorva
AU - Chidester, Paula
AU - Rosenbluth, Kathryn H.
AU - Delp, Scott L.
AU - Pahwa, Rajesh
N1 - Funding Information:
This study was funded by Cala Health, Inc.
Funding Information:
Dr. Luo received research support from the Neurology Foundation at Beth Israel Deaconess Medical Center/Harvard Medical School.
Funding Information:
Dr. Calakos has received research support from NIH, Department of Defense, Dystonia Medical Research Foundation, and Neurocrine Biosciences.
Funding Information:
Dr. Dietiker received research support from Biohaven, CHDI Foundation, Roche, and Michael J. Fox Foundation.
Funding Information:
Dr. Hallett is supported by the NINDS Intramural Program and holds patents for an immunotoxin for the treatment of focal movement disorders and the H-coil for magnetic stimulation; in relation to the latter, he has received license fee payments from the NIH (from Brainsway). He is on the Medical Advisory Boards of Cala Health, Brainsway, and Cadent. He receives royalties and/or honoraria from publishing from Cambridge University Press, Oxford University Press, Springer, and Elsevier. He has research grants from Allergan for studies of methods to inject botulinum toxins, Medtronic, Inc. for a study of DBS for dystonia, and Cala Health for studies of a device to suppress tremor. Dr. Rajagopal is an employee of Cala Health. Ms. Chidester is a former employee of Cala Health.
Funding Information:
Dr. Ondo has served as a consultant/speaker for the following: ACADIA, Acorda, USWorldMeds, Neurocrine, TEVA, and Sunovion as well as received grant support from the following: Sun Pharmaceuticals, Biogen, Lilly, Lundbeck, Sunovion, Revance, Tremor Research Group, NIH, and Restless Legs Syndrome Foundation.
Funding Information:
Dr. Ejaz A. Shamim has received research support from Kinetics Foundation, Allergan (CD PROBE, COMPEL trials), NIEHS (MYORISK study), eNeura (ESPOUSE study) NIH intramural support NINDS NIH, intramural support NIEHS, Mid-Atlantic Permanente Research Institute, Zygood, Gordon and Betty Moore Foundation.
Publisher Copyright:
© 2020 The Author(s).
PY - 2020
Y1 - 2020
N2 - 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% (TET-RAS) 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-re-lated adverse events (e.g., wrist discomfort, skin irritation, pain) occurred in 18% of patients. No device-re-lated 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.
AB - 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% (TET-RAS) 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-re-lated adverse events (e.g., wrist discomfort, skin irritation, pain) occurred in 18% of patients. No device-re-lated 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.
KW - Clinical trials
KW - Neuromodulation
KW - Non-invasive
KW - Stimulation
KW - Tremor
UR - http://www.scopus.com/inward/record.url?scp=85089855679&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85089855679&partnerID=8YFLogxK
U2 - 10.5334/tohm.59
DO - 10.5334/tohm.59
M3 - Article
C2 - 32864188
AN - SCOPUS:85089855679
SN - 2160-8288
VL - 10
SP - 1
EP - 16
JO - Tremor and Other Hyperkinetic Movements
JF - Tremor and Other Hyperkinetic Movements
IS - 1
M1 - 29
ER -