Providence Inland Neurosurgery & Spine
Spokane, Washington, 99204, United States
NCT Number: NCT02424929
The goal of this study is to compare the surgical outcome of deep brain stimulation (DBS) surgery in patients who are deeply sedated, "asleep," or not sedated, "awake," during surgical implantation of the DBS electrode. The investigators hypothesize that the clinical outcome, neurophysiological findings, and surgical accuracy will be equivalent. There are 3 specific aims: 1) compare the activity of the neurons in the patients' brain in the asleep and awake groups using microelectrode recording, to see how this affects clinical outcome capability of microelectrode recordings and macrostimulation to identify the subthalamic nucleus in asleep patients. 2) Determine if intraoperative CT scans of the DBS electrode is sufficient for accurate DBS electrode placement. 3) Compare the clinical outcome on their Parkinson's disease between awake and asleep DBS patients.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Spokane, Washington, 99204, United States
All patients will undergo DBS surgery using regular surgical techniques. In this surgery a halo is attached to the skull. A CT scan is obtained. MRI - based targeting is conducted to identify to target location to implant the electrode deep in the brain. The patients have a burr hole placed just behind their hair line in the frontal lobe. Then a guide tube is inserted in the brain. Neurophysiological identification and confirmation of the target is conducted with multiple techniques including microelectrode recording to listen to single neurons in the brain, and macrostimulation to test clinical effect. The electrode is implanted and its clinical effect is tested. The halo is removed and the patient is taken to the recovery room. Patients will be randomized to undergo the surgery awake or asleep. Our current standard surgical technique is awake with intravenous anesthesia used briefly during drilling of a burr hole in the skull.
But in selected cases patients have remained sedated throughout the entire surgery. Patients in the asleep group will have intravenous anesthesia maintained throughout the entire case.
Standard intraoperative neurophysiological and imaging techniques will be used. In awake patients these techniques are used to identify and confirm that the DBS electrode is implanted in accurate position. These techniques include microelectrode recording where individual neurons are monitored as the electrode is inserted through the brain tissue. Early research reports suggest that sedation may affect the neuronal activity. But our preliminary data indicates that is still reliable under intravenous anesthesia. Macrostimulation using the implanted DBS electrode can suppress tremor, stiffness, and slowness of Parkinson's disease, and assists in confirmation of electrode position. It also causes side effects including tingling, and facial contractions. These methods will also be studied in the asleep patients. The O-arm is an intraoperative CT scanner that visualizes the DBS electrode. O-arm images will be obtained in the standard fashion in both groups. The accuracy of intraoperative imaging will be compared to standard postoperative MRI. The clinical outcome from these two techniques will be compared. The clinical outcome will be measured with standard Parkinson's disease research tools including video taped and independently rated motor exam, as well as the Unified Parkinson's Disease Rating Scale (UPDRS). Gait analysis will be collected using the APDM system. These will be tested before and at 3 months after surgery by the neurologist.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Propofol anesthesia administered during entire surgery.
No intervention, surgery will be conducted as usual. With sedation only during the drilling of the burr holes.
Time frame: 6 months post operation
Determination of location of lead placement and efficacy of programming. x,y,z coordinates related to the anterior commissure and posterior commissure.
Time frame: 6 months post operation
Record stimulation settings. Contacts, voltage, frequency, pulse width.
Time frame: 1 month pre-operation and 6 month post operation
Compare UPDRS score pre and post surgery
Time frame: 1 month pre-operation and 6 month post operation
Compare medication dosage pre and post surgery; mg per dose, dose frequency, total dose, L-dopa equivalent.
Time frame: Day of operation
Microelectrode recordings Anesthesia record; anesthesia dose in reference to Ramsay Scale Stimulation side effects; where parasthesias are present (arm, leg, face), tremor, eye deviation, rigidity, hand speed.
Time frame: 1 month pre-operation and 6 month post operation
Gait evaluation; jerkiness, time-domain (m/s^2, Hz), Frequency, temporal gait, cadence, stride length, range of motion, asymmetry, turning time, number of steps, anticipatory postural amplitude, duration.
Providence Medical Research Center
Other
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