Multicentre RCT of Awake Versus Asleep Tractography Based DBS for ET

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jul 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of deep brain stimulation (DBS) surgery for people with essential tremor, a condition that causes uncontrollable shaking. The trial aims to find out if performing the surgery while the patient is asleep (under general anesthesia) is just as effective in reducing tremors as the traditional method, which requires the patient to be awake and alert. Researchers will evaluate the effectiveness of both methods by measuring tremor levels six months after the surgery.

To participate in this trial, individuals must be at least 18 years old and have disabling essential tremor that hasn't improved with medication. They should also be in good enough health to undergo surgery and have a life expectancy of at least two years. Participants can expect to be randomly assigned to either the asleep or awake surgery group. The trial aims to make DBS a more accessible and less burdensome option for treating essential tremor, potentially benefiting more patients in the long run. Both surgery methods have low risks, and regular follow-ups will ensure participants are monitored throughout the study.

Gender

ALL

Eligibility 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.