NCT02418858

Brief Summary

Recently, there has been increasing interest in performing DBS under general anesthesia, where the stimulated targets are located anatomically (i.e. on MRI) rather than physiologically via microelectrode recordings and intra-operative test stimulation. This technology has been termed "asleep" DBS and is performed with the patient under general anesthesia. Intraoperative imaging is utilized to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery. Because stereotactic accuracy (and surgical safety) is the surgical endpoint, there is no need for the patient to be awake during the procedure.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

March 24, 2015

Last Update Submit

October 8, 2015

Conditions

Essential Tremor

Keywords

Essential tremorDBS

Outcome Measures

Primary Outcomes (2)

  • Functional Outcomes

    The primary data points for this study will include three month functional outcomes using accepted outcome metrics for ET, including an objective tremor rating scale (Fahn-Tolosa-Marin Tremor Rating Scale), a tremor ADL questionnaire (Bain and Findley Tremor ADL scale) for comparison to preoperative scores.

    12 weeks post-operatively

  • Quality of Life Assessment

    Quality of life in Essential Tremor \[QUEST\] questionnaire will be collected again for comparison to preoperative scores.

    12 week post-operatively

Secondary Outcomes (1)

  • Neurocognitive Function

    6 months post-operatively

Other Outcomes (1)

  • Tremor Reduction

    12 weeks post-operatively

Study Arms (2)

Awake DBS Surgery

ACTIVE COMPARATOR

Deep brain stimulation surgery: Essential tremor patients undergoing traditional "awake" DBS surgery utilizing microelectrode recordings and intraoperative stimulation.

Procedure: Deep Brain Stimulation surgery

Asleep DBS Surgery

ACTIVE COMPARATOR

Deep brain stimulation surgery: Essential tremor patients undergoing DBS surgery under general anesthesia utilizing intraoperative imaging to verify the stereotactic accuracy of DBS electrode 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:

  • Essential Tremor diagnosed by criteria listed in the Consensus statement of the Movement Disorders Society on Tremor
  • 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 Essential Tremor
  • 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 and Medical Center

Phoenix, Arizona, 85013, United States

Location

Related Publications (11)

  • Bain PG, Findley LJ, Atchison P, Behari M, Vidailhet M, Gresty M, Rothwell JC, Thompson PD, Marsden CD. Assessing tremor severity. J Neurol Neurosurg Psychiatry. 1993 Aug;56(8):868-73. doi: 10.1136/jnnp.56.8.868.

    PMID: 8350102BACKGROUND

  • Elble R, Bain P, Forjaz MJ, Haubenberger D, Testa C, Goetz CG, Leentjens AF, Martinez-Martin P, Pavy-Le Traon A, Post B, Sampaio C, Stebbins GT, Weintraub D, Schrag A. Task force report: scales for screening and evaluating tremor: critique and recommendations. Mov Disord. 2013 Nov;28(13):1793-800. doi: 10.1002/mds.25648. Epub 2013 Sep 3.

    PMID: 24038576BACKGROUND

  • Flora ED, Perera CL, Cameron AL, Maddern GJ. Deep brain stimulation for essential tremor: a systematic review. Mov Disord. 2010 Aug 15;25(11):1550-9. doi: 10.1002/mds.23195.

    PMID: 20623768BACKGROUND

  • Troster AI, Pahwa R, Fields JA, Tanner CM, Lyons KE. Quality of life in Essential Tremor Questionnaire (QUEST): development and initial validation. Parkinsonism Relat Disord. 2005 Sep;11(6):367-73. doi: 10.1016/j.parkreldis.2005.05.009.

    PMID: 16103000BACKGROUND

  • 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

  • Burchiel KJ, McCartney S, Lee A, Raslan AM. Accuracy of deep brain stimulation electrode placement using intraoperative computed tomography without microelectrode recording. J Neurosurg. 2013 Aug;119(2):301-6. doi: 10.3171/2013.4.JNS122324. Epub 2013 May 31.

    PMID: 23724986BACKGROUND

  • 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

  • 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

  • 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

  • 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

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Francisco A Ponce, MD

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

    PRINCIPAL INVESTIGATOR
0

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

April 16, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

US(1)