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Multicentre RCT of Awake Versus Asleep Tractography Based DBS for ET

RecruitingNAAges 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Ams…
NCT05968976 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 tre

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age \> 18 years; * Idiopathic essential tremor * Disabling tremor despite optimal pharmacological treatment * A life expectancy of at least two years Exclusion Criteria: * Legally incompetent adults; * Previous tremor-neurosurgery (e.g., DBS, thalamotomy); * Contraindications for DBS surgery, such as a physical disorder making surgery hazardous; * Psychosis; * Current depression; * Unable to provide written informed consent.
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What it tests

  • Awake DBS
  • Asleep DBS
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Where

1 site
Amsterdam UMC, location AMC
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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