Parkinson's DiseaseNCT02424929
Asleep Versus Awake Deep Brain Stimulation Surgery
A study testing Sedation and Original Surgery in people with Parkinson's Disease, run by Providence Medical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Sedation and Original Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Patients that are obese or that have severe potential airway issues.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Inland Neurosurgery & Spine
Spokane, Washington, 99204
About this study
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.
Read the detailed description
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.
- Conditions
- Parkinson's Disease
- Being tested
- Sedation, Original Surgery
- Keywords
- Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedationProcedure or surgery
Propofol anesthesia administered during entire surgery.
Original SurgeryProcedure or surgery
No intervention, surgery will be conducted as usual. With sedation only during the drilling of the burr holes.
| Study group | Role | What they receive |
|---|---|---|
| Awake | Other | 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. Receives: Procedure: Original Surgery |
| Asleep | Other | 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. Receives: Procedure: Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead Placement
Determination of location of lead placement and efficacy of programming. x,y,z coordinates related to the anterior commissure and posterior commissure.
Measured: 6 months post operation
Secondary outcomes (5)
Stimulation Parameters
Record stimulation settings. Contacts, voltage, frequency, pulse width.
Measured: 6 months post operation
Unified Parkinson's Disease Rating Scale-UPDRS
Compare UPDRS score pre and post surgery
Measured: 1 month pre-operation and 6 month post operation
Medication Data
Compare medication dosage pre and post surgery; mg per dose, dose frequency, total dose, L-dopa equivalent.
Measured: 1 month pre-operation and 6 month post operation
Operation Data
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.
Measured: Day of operation
Mobiltiy Lab
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.
Measured: 1 month pre-operation and 6 month post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2025
- Study completionMar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan D Carlson, M.D Ph.D., Principal investigator, Inland Neurosurgery and Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424929
- Sponsor's protocol ID
- 1994
- Status last verified
- Apr 2017
- First submitted
- 14 Apr 2015
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asleep Versus Awake Deep Brain Stimulation Surgery
- ClinicalTrials.gov ID
- NCT02424929
- Acronym / sponsor ID
- 1994
- Conditions
- Parkinson's Disease
- Keywords
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Providence Medical Research CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2025 (actual)
- Study completion
- Mar 2025 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awake | Other | Procedure: Original SurgeryOriginal 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. |
| Asleep | Other | Procedure: SedationSedation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
- Patients that are obese or that have severe potential airway issues.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SedationPropofol anesthesia administered during entire surgery. | Procedure or surgery | Asleep |
| Original SurgeryNo intervention, surgery will be conducted as usual. With sedation only during the drilling of the burr holes. | Procedure or surgery | Awake |
Primary outcome
Lead Placement
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.
5 secondary outcomes
Stimulation Parameters
Time frame: 6 months post operation
Unified Parkinson's Disease Rating Scale-UPDRS
Time frame: 1 month pre-operation and 6 month post operation
Medication Data
Time frame: 1 month pre-operation and 6 month post operation
Operation Data
Time frame: Day of operation
Mobiltiy Lab
Time frame: 1 month pre-operation and 6 month post operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan D Carlson, M.D Ph.D. principal investigator
Inland Neurosurgery and Spine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation and Original Surgery in people with Parkinson's Disease, run by Providence Medical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lead Placement (time frame: 6 months post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.