Thalamic DBS with a constant-current device in essential tremor: A controlled clinical trial

Robert E. Wharen, Michael S. Okun, Barton L. Guthrie, Ryan J. Uitti, Paul Larson, Kelly Foote, Harrison Walker, Frederick J. Marshall, Jason Schwalb, Blair Ford, Joseph Jankovic, Richard Simpson, Khashayar Dashtipour, Fenna Phibbs, Joseph S. Neimat, R. Malcolm Stewart, De Lea Peichel, Rajesh Pahwa, Jill L. Ostrem

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Introduction: This study of thalamic deep brain stimulation (DBS) investigated whether a novel constant-current device improves tremor and activities of daily living (ADL) in patients with essential tremor (ET). Methods: A prospective, controlled, multicenter study was conducted at 12 academic centers. We investigated the safety and efficacy of unilateral and bilateral constant-current DBS of the ventralis intermedius (VIM) nucleus of the thalamus in patients with essential tremor whose tremor was inadequately controlled by medications. The primary outcome measure was a rater-blinded assessment of the change in the target limb tremor score in the stimulation-on versus stimulation-off state six months following surgery. Multiple secondary outcomes were assessed at one-year follow-up, including motor, mood, and quality-of-life measures. Results: 127 patients were implanted with VIM DBS. The blinded, primary outcome variable (n = 76) revealed a mean improvement of 1.25 ± 1.26 points in the target limb tremor rating scale (TRS) score in the arm contralateral to DBS (p < 0.001). Secondary outcome variables at one year revealed significant improvements (p ≤ 0.001) in quality of life, depression symptoms, and ADL scores. Forty-seven patients had a second contralateral VIM-DBS, and this group demonstrated reduction in second-sided tremor at 180 days (p < 0.001). Serious adverse events related to the surgery included infection (n = 3), intracranial hemorrhage (n = 3), and device explantation (n = 3). Conclusion: Unilateral and bilateral constant-current VIM DBS significantly improves upper extremity tremor, ADL, quality of life, and depression in patients with severe ET.

Original languageEnglish (US)
JournalParkinsonism and Related Disorders
DOIs
StateAccepted/In press - Jan 6 2017

Fingerprint

Essential Tremor
Deep Brain Stimulation
Controlled Clinical Trials
Tremor
Equipment and Supplies
Activities of Daily Living
Quality of Life
Depression
Ventral Thalamic Nuclei
Intracranial Hemorrhages
Thalamus
Upper Extremity
Multicenter Studies
Arm
Outcome Assessment (Health Care)
Safety
Infection

Keywords

  • Deep brain stimulation
  • Essential tremor
  • Thalamus
  • Ventralis intermedius nucleus

ASJC Scopus subject areas

  • Neurology
  • Geriatrics and Gerontology
  • Clinical Neurology

Cite this

Wharen, R. E., Okun, M. S., Guthrie, B. L., Uitti, R. J., Larson, P., Foote, K., ... Ostrem, J. L. (Accepted/In press). Thalamic DBS with a constant-current device in essential tremor: A controlled clinical trial. Parkinsonism and Related Disorders. https://doi.org/10.1016/j.parkreldis.2017.03.017

Thalamic DBS with a constant-current device in essential tremor : A controlled clinical trial. / Wharen, Robert E.; Okun, Michael S.; Guthrie, Barton L.; Uitti, Ryan J.; Larson, Paul; Foote, Kelly; Walker, Harrison; Marshall, Frederick J.; Schwalb, Jason; Ford, Blair; Jankovic, Joseph; Simpson, Richard; Dashtipour, Khashayar; Phibbs, Fenna; Neimat, Joseph S.; Stewart, R. Malcolm; Peichel, De Lea; Pahwa, Rajesh; Ostrem, Jill L.

In: Parkinsonism and Related Disorders, 06.01.2017.

Research output: Contribution to journalArticle

Wharen, RE, Okun, MS, Guthrie, BL, Uitti, RJ, Larson, P, Foote, K, Walker, H, Marshall, FJ, Schwalb, J, Ford, B, Jankovic, J, Simpson, R, Dashtipour, K, Phibbs, F, Neimat, JS, Stewart, RM, Peichel, DL, Pahwa, R & Ostrem, JL 2017, 'Thalamic DBS with a constant-current device in essential tremor: A controlled clinical trial', Parkinsonism and Related Disorders. https://doi.org/10.1016/j.parkreldis.2017.03.017
Wharen, Robert E. ; Okun, Michael S. ; Guthrie, Barton L. ; Uitti, Ryan J. ; Larson, Paul ; Foote, Kelly ; Walker, Harrison ; Marshall, Frederick J. ; Schwalb, Jason ; Ford, Blair ; Jankovic, Joseph ; Simpson, Richard ; Dashtipour, Khashayar ; Phibbs, Fenna ; Neimat, Joseph S. ; Stewart, R. Malcolm ; Peichel, De Lea ; Pahwa, Rajesh ; Ostrem, Jill L. / Thalamic DBS with a constant-current device in essential tremor : A controlled clinical trial. In: Parkinsonism and Related Disorders. 2017.
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T1 - Thalamic DBS with a constant-current device in essential tremor

T2 - A controlled clinical trial

AU - Wharen, Robert E.

AU - Okun, Michael S.

AU - Guthrie, Barton L.

AU - Uitti, Ryan J.

AU - Larson, Paul

AU - Foote, Kelly

AU - Walker, Harrison

AU - Marshall, Frederick J.

AU - Schwalb, Jason

AU - Ford, Blair

AU - Jankovic, Joseph

AU - Simpson, Richard

AU - Dashtipour, Khashayar

AU - Phibbs, Fenna

AU - Neimat, Joseph S.

AU - Stewart, R. Malcolm

AU - Peichel, De Lea

AU - Pahwa, Rajesh

AU - Ostrem, Jill L.

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N2 - Introduction: This study of thalamic deep brain stimulation (DBS) investigated whether a novel constant-current device improves tremor and activities of daily living (ADL) in patients with essential tremor (ET). Methods: A prospective, controlled, multicenter study was conducted at 12 academic centers. We investigated the safety and efficacy of unilateral and bilateral constant-current DBS of the ventralis intermedius (VIM) nucleus of the thalamus in patients with essential tremor whose tremor was inadequately controlled by medications. The primary outcome measure was a rater-blinded assessment of the change in the target limb tremor score in the stimulation-on versus stimulation-off state six months following surgery. Multiple secondary outcomes were assessed at one-year follow-up, including motor, mood, and quality-of-life measures. Results: 127 patients were implanted with VIM DBS. The blinded, primary outcome variable (n = 76) revealed a mean improvement of 1.25 ± 1.26 points in the target limb tremor rating scale (TRS) score in the arm contralateral to DBS (p < 0.001). Secondary outcome variables at one year revealed significant improvements (p ≤ 0.001) in quality of life, depression symptoms, and ADL scores. Forty-seven patients had a second contralateral VIM-DBS, and this group demonstrated reduction in second-sided tremor at 180 days (p < 0.001). Serious adverse events related to the surgery included infection (n = 3), intracranial hemorrhage (n = 3), and device explantation (n = 3). Conclusion: Unilateral and bilateral constant-current VIM DBS significantly improves upper extremity tremor, ADL, quality of life, and depression in patients with severe ET.

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KW - Deep brain stimulation

KW - Essential tremor

KW - Thalamus

KW - Ventralis intermedius nucleus

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