Clinical Trial: Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Essential Tremor
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Randomized Controlled Clinical Trial Comparing Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Essential Tremor
Brief Summary: 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.
Detailed Summary:
Traditional DBS is performed without general anesthesia with the patient awake. Local anesthetic is used to numb the skin and tissue where the incision is made, and the patients are given mild sedatives to alleviate anxiety and discomfort. Essential tremor (ET) patients undergo intra-operative test stimulation to refine the lead location and ensure the absence of sustained side effects. This can result in multiple brain penetrations during lead placement, and the entire procedure may last anywhere from 4-6 hours on average. The concept of being awake during brain surgery provokes significant anxiety and fear in some patients.
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.
If asleep DBS produces clinical results equivalent to awake DBS surgery, the possible advantages include shorter surgical time, improved patient comfort, better access to DBS for patients, and cost savings for the hospital.
To date (August 2011 - September 2014), 157 patients have undergone asleep DBS surgery and 141 patients have undergone traditional awake DBS surgery. ET patients constitute 76 of the total surgeries - 50 patients underwent awake surgery and 26 underwent asleep surgery. The safety and efficacy of the two appro
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Current Primary Outcome:
- Functional Outcomes [ Time Frame: 12 weeks post-operatively ]The primary data points for this study will include three month functional outcomes using accepted outcome metrics for ET, including an objective tremor rating scale (Fahn-Tolosa-Marin Tremor Rating Scale), a tremor ADL questionnaire (Bain and Findley Tremor ADL scale) for comparison to preoperative scores.
- Quality of Life Assessment [ Time Frame: 12 week post-operatively ]Quality of life in Essential Tremor [QUEST] questionnaire will be collected again for comparison to preoperative scores.
Original Primary Outcome: Same as current
Current Secondary Outcome: Neurocognitive Function [ Time Frame: 6 months post-operatively ]
Original Secondary Outcome: Same as current
Information By: St. Joseph's Hospital and Medical Center, Phoenix
Dates:
Date Received: March 24, 2015
Date Started: February 2015
Date Completion: June 2017
Last Updated: October 8, 2015
Last Verified: October 2015