An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor

Objective To evaluate the safety and effectiveness of a wrist‐worn peripheral nerve stimulation device in patients with essential tremor (ET) in a single in‐office session. Methods This was a randomized controlled study of 77 ET patients who received either treatment stimulation (N = 40) or sham sti...

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Published inNeuromodulation (Malden, Mass.) Vol. 22; no. 5; pp. 537 - 545
Main Authors Pahwa, Rajesh, Dhall, Rohit, Ostrem, Jill, Gwinn, Ryder, Lyons, Kelly, Ro, Susie, Dietiker, Cameron, Luthra, Nijee, Chidester, Paula, Hamner, Samuel, Ross, Erika, Delp, Scott
Format Journal Article
LanguageEnglish
Published United States Elsevier Limited 01.07.2019
John Wiley and Sons Inc
Subjects
Activities of daily living
Activities of Daily Living - psychology
Aged
Aged, 80 and over
Clinical Trials
Essential tremor
Essential Tremor - diagnosis
Essential Tremor - physiopathology
Essential Tremor - therapy
Female
Hand
Humans
Male
Middle Aged
movement disorders
neurostimulation
noninvasive stimulation
Patients
PERIPHERAL NERVE STIMULATION
Peripheral nerves
Peripheral Nerves - physiology
Transcutaneous Electric Nerve Stimulation - instrumentation
Transcutaneous Electric Nerve Stimulation - methods
Tremor
Wrist
Wrist - innervation
Wrist - physiology
tremor
movement disorders
Essential tremor
peripheral nerve stimulation
neurostimulation
noninvasive stimulation
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Summary:Objective To evaluate the safety and effectiveness of a wrist‐worn peripheral nerve stimulation device in patients with essential tremor (ET) in a single in‐office session. Methods This was a randomized controlled study of 77 ET patients who received either treatment stimulation (N = 40) or sham stimulation (N = 37) on the wrist of the hand with more severe tremor. Tremor was evaluated before and immediately after the end of a single 40‐minute stimulation session. The primary endpoint compared spiral drawing in the stimulated hand using the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Archimedes spiral scores in treatment and sham groups. Additional endpoints included TETRAS upper limb tremor scores, subject‐rated tasks from the Bain and Findley activities of daily living (ADL) scale before and after stimulation as well as clinical global impression‐improvement (CGI‐I) rating after stimulation. Results Subjects who received peripheral nerve stimulation did not show significantly larger improvement in the Archimedes spiral task compared to sham but did show significantly greater improvement in upper limb TETRAS tremor scores (p = 0.017) compared to sham. Subject‐rated improvements in ADLs were significantly greater with treatment (49% reduction) than with sham (27% reduction; p = 0.001). A greater percentage of ET patients (88%) reported improvement in the stimulation group as compared to the sham group (62%) according to CGI‐I ratings (p = 0.019). No significant adverse events were reported; 3% of subjects experienced mild adverse events. Conclusions Peripheral nerve stimulation in ET may provide a safe, well‐tolerated, and effective treatment for transient relief of hand tremor symptoms.
Bibliography:Dr. Pahwa has received consulting fees from Abbvie, Abbott, ACADIA, Acorda, Adamas, Cala Health, Cynapsus, Global Kinetics, Ionis, Lundbeck, Neurocrine, Sunovion, Teva Neuroscience, UCB, and US World Meds. He has received research grants from Abbott, AbbVie, Acorda, Adamas, Biogen, BMS, Boston Scientific, Cala Health, Cavion, Cynapsus, Intec, Jazz, Kyowa, Lilly, Parkinson's Foundation, NIH/NINDS, Parkinson Study Group, Pfizer, Roche, Sunovion, and US WorldMeds. Dr. Dhall is an investigator for Cala Health, Inc., and has served as a consultant for Impax, Merz, Teva, and Acadia Pharmaceuticals. Dr. Ostrem received research support from NIH grants R01NS090913, UH3NS100544, DARPA contract W911NF1420043, ad PCORI contract 782.002 as a co‐investigator. Dr. Ostrem also has received research grant support from The National Parkinson Foundation, Michael J. Fox Foundation, Boston Scientific, St Jude Medical, Cala Health, Google, Sangamo, and Biogen. She has been a consultant for Abbvie, Neurocrine, Medtronic, and Adamas Pharmaceutics. She receives programmatic fellowship training support from Medtronic, Abbvie, Boston Scientific, and Allergan. Dr. Lyons has received consulting fees from ACADIA, Parkinson's Foundation, and Sage Therapeutics. She is also President of the International Essential Tremor Foundation. Dr. Ross is employed by Cala Health, Inc. and receives research support at the Mayo Clinic from DARPA contracts N66001‐17‐2‐4010 and N66001‐17‐2‐4018. Dr. Hamner and Ms. Chidester are employed by Cala Health, Inc. Dr. Delp has received research support from NIH grants U54 EB020405, P2C HD065690, R01 GM107340, R01 NS080954, and DARPA contract W911QX12C0018 on which he is the principal investigator. He also has received support from NIH grant R01 EB009351 as a co‐investigator. Dr. Delp is a consultant, scientific advisor, and board member of Cala Health, Inc., Circuit Therapeutics Inc., and Zebra Medical Technologies, Inc. and receives compensation for this service. Drs. Ro, Gwinn, and Luthra have no potential conflict of interest to report.
Conflict of Interest
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Conflict of Interest: Dr. Pahwa has received consulting fees from Abbvie, Abbott, ACADIA, Acorda, Adamas, Cala Health, Cynapsus, Global Kinetics, Ionis, Lundbeck, Neurocrine, Sunovion, Teva Neuroscience, UCB, and US World Meds. He has received research grants from Abbott, AbbVie, Acorda, Adamas, Biogen, BMS, Boston Scientific, Cala Health, Cavion, Cynapsus, Intec, Jazz, Kyowa, Lilly, Parkinson's Foundation, NIH/NINDS, Parkinson Study Group, Pfizer, Roche, Sunovion, and US WorldMeds. Dr. Dhall is an investigator for Cala Health, Inc., and has served as a consultant for Impax, Merz, Teva, and Acadia Pharmaceuticals. Dr. Ostrem received research support from NIH grants R01NS090913, UH3NS100544, DARPA contract W911NF1420043, ad PCORI contract 782.002 as a co‐investigator. Dr. Ostrem also has received research grant support from The National Parkinson Foundation, Michael J. Fox Foundation, Boston Scientific, St Jude Medical, Cala Health, Google, Sangamo, and Biogen. She has been a consultant for Abbvie, Neurocrine, Medtronic, and Adamas Pharmaceutics. She receives programmatic fellowship training support from Medtronic, Abbvie, Boston Scientific, and Allergan. Dr. Lyons has received consulting fees from ACADIA, Parkinson's Foundation, and Sage Therapeutics. She is also President of the International Essential Tremor Foundation. Dr. Ross is employed by Cala Health, Inc. and receives research support at the Mayo Clinic from DARPA contracts N66001‐17‐2‐4010 and N66001‐17‐2‐4018. Dr. Hamner and Ms. Chidester are employed by Cala Health, Inc. Dr. Delp has received research support from NIH grants U54 EB020405, P2C HD065690, R01 GM107340, R01 NS080954, and DARPA contract W911QX12C0018 on which he is the principal investigator. He also has received support from NIH grant R01 EB009351 as a co‐investigator. Dr. Delp is a consultant, scientific advisor, and board member of Cala Health, Inc., Circuit Therapeutics Inc., and Zebra Medical Technologies, Inc. and receives compensation for this service. Drs. Ro, Gwinn, and Luthra have no potential conflict of interest to report.
Source(s) of financial support: Supported by Cala Health, Inc.
ISSN:1094-7159
1525-1403
1525-1403
DOI:10.1111/ner.12930