Highlights
- •A novel constant-current DBS device for patients with essential tremor.
- •A prospective, controlled, multicenter study confirms the efficacy of thalamic DBS.
- •Constant-current DBS may offer advantages over constant voltage devices.
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.
Keywords
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Article info
Publication history
Published online: March 29, 2017
Accepted:
March 28,
2017
Received in revised form:
March 10,
2017
Received:
January 6,
2017
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© 2017 Elsevier Ltd. All rights reserved.
