Comparing awake and asleep deep brain stimulation for essential tremor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of awake versus asleep deep brain stimulation (DBS) for patients with essential tremor who have not responded adequately to medication. The study will utilize advanced imaging techniques to visualize the target area in the thalamus during surgery. Participants will be assessed for tremor reduction and quality of life six months post-surgery, alongside evaluating operation time and patient satisfaction. The trial is multicenter, involving several hospitals in the Netherlands.

Why it matters

Who can join: the full rules

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.

Where it's running

• Amsterdam UMC, location AMC
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Maarten Bot, MD, PhD
• Email: m.bot@amsterdamumc.nl
• Phone: 0031621514048

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.