Status:
RECRUITING
Multicentre RCT of Awake Versus Asleep Tractography Based DBS for ET
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
University Medical Center Groningen
Medical Center Haaglanden
Conditions:
Essential Tremor
Deep Brain Stimulation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 standar...
Detailed Description
INTRODUCTION AND RATIONALE Essential tremor Essential tremor is the most common neurological movement disorder and often begins at an early age. In 20 to 30 years, the disorder develops to an advance...
Eligibility Criteria
Inclusion
- Age \> 18 years;
- Idiopathic essential tremor
- Disabling tremor despite optimal pharmacological treatment
- A life expectancy of at least two years
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05968976
Start Date
February 1 2024
End Date
July 1 2028
Last Update
April 13 2025
Active Locations (1)
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1
Amsterdam UMC, location AMC
Amsterdam, North Holland, Netherlands, 11015AZ