Clinical Trial

Asleep Versus Awake Deep Brain Stimulation Surgery

Study Description

Asleep Versus Awake Deep Brain Stimulation Surgery

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Procedure - Sedation

Propofol anesthesia administered during entire surgery.

Procedure - Original Surgery

No intervention, surgery will be conducted as usual. With sedation only during the drilling of the burr holes.

Additional Information

Official Study Title

Asleep Versus Awake Deep Brain Stimulation Surgery

Clinical Trial ID

NCT02424929

ParticipAid ID

PdR8za