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

Area of Science:

• Neurology
• Neurosurgery
• Biomedical Engineering

Background:

• Essential tremor (ET) is a neurological disorder characterized by involuntary shaking.
• Current treatments for ET, including medication, are often insufficient for severe cases.
• Deep brain stimulation (DBS) is an established therapy, but novel devices are being explored.

Purpose of the Study:

• To investigate the efficacy and safety of a novel constant-current deep brain stimulation (DBS) device targeting the ventralis intermedius (VIM) nucleus of the thalamus.
• To assess the impact of unilateral and bilateral VIM DBS on tremor severity and activities of daily living (ADL) in patients with essential tremor (ET).

Main Methods:

• A prospective, controlled, multicenter study involving 127 patients with medication-refractory ET.
• Patients received unilateral or bilateral constant-current VIM DBS.
• Primary outcome: rater-blinded assessment of tremor score change at six months.
• Secondary outcomes: motor function, mood, quality of life at one-year follow-up.

Main Results:

• A significant improvement in tremor scores was observed in the target limb contralateral to DBS (p < 0.001).
• Bilateral DBS also led to a reduction in second-sided tremor (p < 0.001).
• Significant improvements were noted in quality of life, depression symptoms, and ADL scores at one year (p ≤ 0.001).
• Adverse events included infection, intracranial hemorrhage, and device explantation (n=3 each).

Conclusions:

• Unilateral and bilateral constant-current VIM DBS is a safe and effective treatment for severe essential tremor.
• The novel device significantly improves tremor, ADL, quality of life, and depression in ET patients.
• This technology represents a promising advancement in managing essential tremor.