The TREMBLE study: Multicentre randomized controlled trial of awake versus asleep tractography based 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 - TREMBLE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53748

Enrollment

110

Registered

2023-01-20

Start date

2024-02-07

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential tremor

Interventions

Patients are randomized for DBS under general anesthesia or DBS under local anesthesia. According to the standard DBS procedure, two brain-electrodes are connected to an implanted neurostimulator, whi

Eligibility

Age

18 Years to 64 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the amount of decrease in tremor indicated by change in the Essential Tremor Rating Assessment Scale score after 6 months of thalamic DBS.	—

Secondary

Measure	Time frame
The Amsterdam Linear Disability Score for functional health statusQuality of Life in Essential Tremor QuestionnairePatient satisfaction with the treatmentPatient evaluation of treatment burdenOperating timeHospitalization timeChange of tremor medicationSide effects and complications	—

Countries

Netherlands

Contacts

Public ContactM. Bot

Amsterdam UMC

m.bot@amsterdamumc.nl0621514048

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)