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Awake for Parkinson's Disease

N/A
Waitlist Available
Led By Jonathan D Carlson, M.D Ph.D.
Research Sponsored by Providence Medical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month pre-operation and 6 month post operation
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month pre-operation and 6 month post operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month pre-operation and 6 month post operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Lead Placement
Secondary study objectives
Medication Data
Mobiltiy Lab
Operation Data
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: AwakeExperimental Treatment1 Intervention
Original surgery intervention. Patient will have DBS surgery done in the normal fashion. Asleep for the drilling of the burr holes, then awakened for the placement of the electrodes. No intervention will be given.
Group II: AsleepExperimental Treatment1 Intervention
Sedation intervention. Surgical intervention, anesthesia will be administered during entire placement of the system. Patient will not be awake at any point during procedure. All other aspects of surgery will be conducted normally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sedation
2014
Completed Phase 4
~490

Find a Location

Who is running the clinical trial?

Providence Medical Research CenterLead Sponsor
9 Previous Clinical Trials
899 Total Patients Enrolled
Jonathan D Carlson, M.D Ph.D.Principal InvestigatorInland Neurosurgery and Spine
~9 spots leftby Nov 2025