Condition: Essential Tremor · Deep Brain Stimulation · Diffusion Tensor Imaging · Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rationale: Deep brain stimulation (DBS) of the thalamus is an effective surgical treatment for patients with disabling essential tremor, despite optimal pharmacological treatment. To date, the standard DBS procedure is performed under local anesthesia which is very burdensome for patients. It is now possible to directly visualize the target (motor) area in the thalamus due to advances in modern imaging techniques. DBS surgery could be performed under general anesthesia (asleep). Objective: The primary objective of the study is to determine whether asleep thalamic DBS surgery provides an equal tremor reduction compared to awake thalamic DBS surgery, measured by the clinically validated Essential Tremor Rating Assessment Scale after six months of DBS. Secondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life, patient satisfaction with treatment outcome and patient evaluation of treatment burden. Study design: The study will be a multicentre prospective randomized open label blinded (PROBE) endpoint trial comparing thalamic DBS under general versus local anesthesia. Study population: A total of 110 patients with disabling essential tremor despite optimal pharmacological treatment will be randomized. Intervention (if applicable): Patients will be randomized for asleep DBS or awake DBS. According to the standard DBS procedure, two brain-electrodes are connected to an implanted neurostimulator, which is placed subcutaneously in…
This description comes directly from the study's public registry record.
Maarten Bot, MD, PhD · 0031621514048 · m.bot@amsterdamumc.nl
Richard Schuurman, Md, PhD, professor · 0031626908484 · p.r.schuurman@amsterdamumc.nl
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| Amsterdam UMC, location AMC | Amsterdam, North Holland, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05968976