NCT02424929

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 11, 2025

Status Verified

April 1, 2017

Enrollment Period

9.9 years

First QC Date

April 14, 2015

Last Update Submit

March 6, 2025

Conditions

Parkinson's Disease

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • Lead Placement

    Determination of location of lead placement and efficacy of programming. x,y,z coordinates related to the anterior commissure and posterior commissure.

    6 months post operation

Secondary Outcomes (5)

  • Stimulation Parameters

    6 months post operation

  • Unified Parkinson's Disease Rating Scale-UPDRS

    1 month pre-operation and 6 month post operation

  • Medication Data

    1 month pre-operation and 6 month post operation

  • Operation Data

    Day of operation

  • Mobiltiy Lab

    1 month pre-operation and 6 month post operation

Study Arms (2)

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.

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.

Procedure: Sedation

Interventions

SedationPROCEDURE

Propofol anesthesia administered during entire surgery.

Asleep
Original SurgeryPROCEDURE

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

Awake

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Inland Neurosurgery & Spine

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Jonathan D Carlson, M.D Ph.D.

    Inland Neurosurgery and Spine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Randomized parallel assignment, unblinded
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 23, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 11, 2025

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Locations

US(1)