Comparing awake and asleep deep brain stimulation for essential tremor
The TREMBLE Study: Multicentre Randomized Controlled Trial of Awake Versus Asleep Tractography Based Deep Brain Stimulation for Essential Tremor
This study is testing whether deep brain stimulation done while patients are awake works better than when it's done while they're asleep for people with essential tremor who haven't found relief with medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT05968976 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with idiopathic essential tremor that severely limits their daily functioning despite optimal medication.
Not a fit: Patients with previous tremor-related neurosurgery or those with contraindications for DBS surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less burdensome surgical option for patients with essential tremor, improving their quality of life.
How similar studies have performed: While deep brain stimulation has been established as an effective treatment for essential tremor, the comparison of awake versus asleep techniques is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amsterdam, North Holland
- Amsterdam UMC, location AMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Maarten Bot, MD, PhD
- Email: m.bot@amsterdamumc.nl
- Phone: 0031621514048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.