Essential Tremor study: Awake DBS vs Asleep DBS
Official title Multicentre RCT of Awake Versus Asleep Tractography Based DBS for ET
ClinicalTrials.gov ID: NCT05968976
What this study is testing
- What it's testing
- This study is testing whether deep brain stimulation surgery performed under general anesthesia (asleep) reduces tremor as much as surgery done while you are awake. It also looks at how the two methods affect daily life, side effects, and how long the operation takes.
- Who it's for
- You may be able to join if you have disabling essential tremor that does not improve with medication and you are a candidate for deep brain stimulation surgery.
- What's involved
- You will be randomly assigned to have the surgery while you are asleep or while you are awake. The surgery places two electrodes in your brain and a small device under your skin. After the operation you will have follow‑up visits to check your tremor and any side effects.
- Time commitment
- The study lasts about six months after surgery, with several follow‑up visits during that time.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18 years;
- Idiopathic essential tremor
- Disabling tremor despite optimal pharmacological treatment
- A life expectancy of at least two years
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.