Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Essential Tremor

Withdrawn before enrolling · Not applicable

Conditions studied: Essential Tremor

In brief

Recently, there has been increasing interest in performing DBS under general anesthesia, where the stimulated targets are located anatomically (i.e. on MRI) rather than physiologically via microelectrode recordings and intra-operative test stimulation. This technology has been termed "asleep" DBS and is performed with the patient under general anesthesia. Intraoperative imaging is utilized to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery. Because stereotactic accuracy (and surgical safety) is the surgical endpoint, there is no need for the patient to be awake during the procedure.

Key facts

Study ID

NCT02418858

Run by

St. Joseph's Hospital and Medical Center, Phoenix

People needed

0

Starts

2015-02-01

Expected to finish

2017-06-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Essential Tremor diagnosed by criteria listed in the Consensus statement of the Movement Disorders Society on Tremor
• Age 18 - 85 years of age
• Motor skills allowing for capability to complete evaluations
• Medically cleared for undergoing anesthesia and DBS surgery

You may not qualify if…

• Dementia per DSM-V criteria
• Medical or other condition precluding MRI
• History of supraspinal CNS disease other than Essential Tremor
• Alcohol use of more than 4 drinks per day
• Pregnancy
• History of suicide attempt
• Currently uncontrolled clinically significant depression (BDI>20)
• History of schizophrenia, delusions, or currently uncontrolled visual hallucinations

Where it is running

• Barrow Neurological Institute / St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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