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

被引：40

作者：

Isaacson, Stuart H. ^{[1
]}

Peckham, Elizabeth ^{[2
]}

Tse, Winona ^{[3
]}

Waln, Olga ^{[4
]}

Way, Christopher ^{[5
]}

Petrossian, Melita T. ^{[6
]}

Dahodwala, Nabila ^{[7
]}

Soileau, Michael J. ^{[8
]}

Lew, Mark ^{[9
]}

Dietiker, Cameron ^{[10
]}

Luthra, Nijee ^{[10
]}

Agarwal, Pinky ^{[11
]}

Dhall, Rohit ^{[12
]}

Morgan, John ^{[13
]}

Calakos, Nicole ^{[14
]}

Zesiewicz, Theresa A. ^{[15
]}

Shamim, Ejaz A. ^{[16
]}

Kumar, Rajeev ^{[17
]}

LeWitt, Peter ^{[18
]}

Shill, Holly A. ^{[19
]}

Simmons, Adam ^{[20
]}

Pagan, Fernando L. ^{[21
]}

Khemani, Pravin ^{[22
]}

Tate, Jessica ^{[23
]}

Maddux, Brian ^{[24
]}

Luo, Lan ^{[25
]}

Ondo, William ^{[4
]}

Hallett, Mark ^{[26
]}

Rajagopal, Apoorva ^{[27
]}

Chidester, Paula ^{[27
]}

Rosenbluth, Kathryn H. ^{[27
]}

Delp, Scott L. ^{[28
]}

Pahwa, Rajesh ^{[29
]}

机构：

[1] Parkinsons Dis & Movement Disorders Boca Raton, Boca Raton, FL USA

[2] Cent Texas Neurol Consultants, Round Rock, TX USA

[3] Mt Sinai Hosp, Dept Neurol, New York, NY 10029 USA

[4] Houston Methodist, Dept Neurol, Houston, TX USA

[5] Parkinsons Inst & Clin Ctr, Mountain View, CA USA

[6] Pacific Movement Disorders Ctr, Pacific Neurosci Inst, Santa Monica, CA USA

[7] Univ Penn, Dept Neurol, Philadelphia, PA 19104 USA

[8] Texas Movement Disorders Specialists, Georgetown, TX USA

[9] Univ Southern Calif, Dept Neurol, Los Angeles, CA 90007 USA

[10] Univ Calif San Francisco, Movement Disorder Ano Neuromodulat Ctr, San Francisco, CA 94143 USA

[11] EvergreenHlth, Dept Neurol, Kirkland, WA USA

[12] Univ Arkansas Med Sci, Dept Neurol, Little Rock, AR 72205 USA

[13] Augusta Univ, Dept Neurol, Augusta, GA USA

[14] Duke Univ, Sch Med, Dept Neurol, Durham, NC USA

[15] Univ South Florida Hlth, Dept Neurol, Tampa, FL USA

[16] MidAtlantic Permanente Res Inst, Kaiser Permanente MidAtlantic States, Dept Neurol, Largo, MD USA

[17] Rocky Mt Movement Disorders Ctr, Englewood, CO USA

[18] Henry Ford Hlth Syst, Dept Neurol, West Bloomfield, MI USA

[19] Barrow Neurol Inst, Dept Neurol, Phoenix, AZ 85013 USA

[20] Hosp Special Care, Dept Res, New Britain, CT USA

[21] Georgetown Univ, Med Ctr, Dept Neurol, Washington, DC USA

[22] Swedish Neurosci Inst, Dept Neurol, Seattle, WA USA

[23] Wake Forest Baptist Hlth, Dept Neurol, Winston Salem, NC USA

[24] Riverhills Neurosci, Cincinnati, OH USA

[25] Harvard Med Sch, Beth Israel Deaconess Med Ctr, Dept Neurol, Boston, MA 02115 USA

[26] NINDS, Human Motor Control Sect, Bethesda, MD USA

[27] Cala Hlth, Burlingame, CA USA

[28] Stanford Univ, Dept Bioengn, Stanford, CA 94305 USA

[29] Univ Kansas, Med Ctr, Dept Neurol, Kansas City, KS 66103 USA

来源：

TREMOR AND OTHER HYPERKINETIC MOVEMENTS | 2020年 / 10卷

关键词：

clinical trials; tremor; neuromodulation; stimulation; non-invasive; DEEP BRAIN-STIMULATION; PARKINSONS-DISEASE; TASK-FORCE; TRIAL; RECOMMENDATIONS; PRIMIDONE; SCALE;

D O I：

10.5334/tohm.59

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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-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.

引用

页码：1 / 16

页数：16

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