NCT02424929Completed
Asleep Versus Awake Deep Brain Stimulation Surgery
Source: ClinicalTrials.gov · Last updated 11 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 14 Apr 2015
- Start date
- 1 Apr 2015
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Providence Medical Research Center
- Diseases
- Parkinson disease
- NCT number
- NCT02424929
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 1 Apr 2015 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Parkinson's patients with concurrent dementia as measured by neurocognitive testing, or with significant strokes identified on MRI will be excluded. Other similar diseases will be excluded from the study such as Essential Tremor, and Parkinson's plus disorders.
Other
- Patients that are obese or that have severe potential airway issues.
Who the study is looking for
- All patients will have moderate to advanced Parkinson's disease.
- Patients must be medically safe for asleep or awake surgery.
- Ability to speak English well.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Providence Inland Neurosurgery & Spine Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.