NCT02401308

Brief Summary

The purpose of the proposed study is to demonstrate that the functional outcomes of DBS surgery utilizing the "asleep" technique are not inferior to those reported for traditional "awake" DBS technique.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2015

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

October 26, 2021

Completed
Last Updated

October 26, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

March 24, 2015

Results QC Date

September 27, 2021

Last Update Submit

September 27, 2021

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Functional Outcomes

    Motor function outcomes using accepted metrics for Parkinson's disease - the Unified Parkinson's Disease Rating Scale \[UPDRS\] obtained in 3 states: 1. medication "off" / device "on". 2. Medication "off" / device "off" 3. medication "on" / device "on"

    6 months post-operatively

Secondary Outcomes (2)

  • Neurocognitive Function

    6 months post-operatively

  • Quality of Life

    6 months post-operatively

Study Arms (2)

Awake DBS Surgery

ACTIVE COMPARATOR

Deep brain stimulation surgery: Parkinson's patients undergoing traditional "awake" DBS surgery utilizing microelectrode recordings and intra-operative stimulation

Procedure: Deep Brain Stimulation surgery

Asleep DBS Surgery

ACTIVE COMPARATOR

Deep brain stimulation surgery:Parkinson's patients undergoing DBS surgery under general anesthesia utilizing intraoperative imaging to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery.

Procedure: Deep Brain Stimulation surgery

Interventions

Deep Brain Stimulation surgeryPROCEDURE

Deep Brain Stimulation surgery: awake vs. asleep

Also known as: DBS
Asleep DBS SurgeryAwake DBS Surgery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease per Queens Square criteria
  • Appropriate DBS candidate for multi-disciplinary team consensus
  • Age 18 - 85 years of age
  • Motor skills allowing for capability to complete evaluations
  • Medically cleared for undergoing anesthesia and DBS surgery

You may not qualify if:

  • Dementia per DSM-V criteria
  • Medical or other condition precluding MRI
  • History of supraspinal CNS disease other than PD
  • Alcohol use of more than 4 drinks per day
  • Pregnancy
  • History of suicide attempt
  • Currently uncontrolled clinically significant depression (BDI\>20)
  • History of schizophrenia, delusions, or currently uncontrolled visual hallucinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barrow Neurological Institute / St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

Related Publications (8)

  • Ostrem JL, Galifianakis NB, Markun LC, Grace JK, Martin AJ, Starr PA, Larson PS. Clinical outcomes of PD patients having bilateral STN DBS using high-field interventional MR-imaging for lead placement. Clin Neurol Neurosurg. 2013 Jun;115(6):708-12. doi: 10.1016/j.clineuro.2012.08.019. Epub 2012 Sep 1.

    PMID: 22944465BACKGROUND

  • Nakajima T, Zrinzo L, Foltynie T, Olmos IA, Taylor C, Hariz MI, Limousin P. MRI-guided subthalamic nucleus deep brain stimulation without microelectrode recording: can we dispense with surgery under local anaesthesia? Stereotact Funct Neurosurg. 2011;89(5):318-25. doi: 10.1159/000330379. Epub 2011 Sep 15.

    PMID: 21921673BACKGROUND

  • Harries AM, Kausar J, Roberts SA, Mocroft AP, Hodson JA, Pall HS, Mitchell RD. Deep brain stimulation of the subthalamic nucleus for advanced Parkinson disease using general anesthesia: long-term results. J Neurosurg. 2012 Jan;116(1):107-13. doi: 10.3171/2011.7.JNS11319. Epub 2011 Oct 14.

    PMID: 21999316BACKGROUND

  • Weaver FM, Follett K, Stern M, Hur K, Harris C, Marks WJ Jr, Rothlind J, Sagher O, Reda D, Moy CS, Pahwa R, Burchiel K, Hogarth P, Lai EC, Duda JE, Holloway K, Samii A, Horn S, Bronstein J, Stoner G, Heemskerk J, Huang GD; CSP 468 Study Group. Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson disease: a randomized controlled trial. JAMA. 2009 Jan 7;301(1):63-73. doi: 10.1001/jama.2008.929.

    PMID: 19126811BACKGROUND

  • Pezeshkian P, DeSalles AA, Gorgulho A, Behnke E, McArthur D, Bari A. Accuracy of frame-based stereotactic magnetic resonance imaging vs frame-based stereotactic head computed tomography fused with recent magnetic resonance imaging for postimplantation deep brain stimulator lead localization. Neurosurgery. 2011 Dec;69(6):1299-306. doi: 10.1227/NEU.0b013e31822b7069.

    PMID: 21725253BACKGROUND

  • Papanastassiou V, Rowe J, Scott R, Silburn P, Davies L, Aziz T. Use of the Radionics Image Fusiontrade mark and Stereoplantrade mark programs for target localization in functional neurosurgery. J Clin Neurosci. 1998 Jan;5(1):28-32. doi: 10.1016/s0967-5868(98)90197-7.

    PMID: 18644283BACKGROUND

  • Alexander E 3rd, Kooy HM, van Herk M, Schwartz M, Barnes PD, Tarbell N, Mulkern RV, Holupka EJ, Loeffler JS. Magnetic resonance image-directed stereotactic neurosurgery: use of image fusion with computerized tomography to enhance spatial accuracy. J Neurosurg. 1995 Aug;83(2):271-6. doi: 10.3171/jns.1995.83.2.0271.

    PMID: 7616273BACKGROUND

  • Kooy HM, van Herk M, Barnes PD, Alexander E 3rd, Dunbar SF, Tarbell NJ, Mulkern RV, Holupka EJ, Loeffler JS. Image fusion for stereotactic radiotherapy and radiosurgery treatment planning. Int J Radiat Oncol Biol Phys. 1994 Mar 30;28(5):1229-34. doi: 10.1016/0360-3016(94)90499-5.

    PMID: 8175410BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This trial was terminated without meeting the objectives. One out of the planned 120 participants was enrolled. There was no analysis completed.

Results Point of Contact

Title
Lisa Arnold - Operations Manager Neurosurgery Clinical Research
Organization
St. Joseph's Hospital and Medical Center
lisa.arnold@dignityhealth.org
602-406-9593

Study Officials

  • Francisco A Ponce, MD

    Barrow Neurological Institute / St. Joseph's Hosptial and Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2015

First Posted

March 27, 2015

Study Start

January 15, 2015

Primary Completion

October 5, 2015

Study Completion

October 5, 2015

Last Updated

October 26, 2021

Results First Posted

October 26, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)