DBS Under General Anesthesia: Comparison To The Standard Technique

NCT01997398 | Completed Results

• 1 other identifier: 12BN123
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

There is a growing trend in functional neurosurgery toward direct anatomical targeting for deep brain stimulation (DBS). This study describes a method and reports the initial experience placing DBS electrodes under general anesthesia without the use of microelectrode recordings (MER), using a portable head CT scanner to verify accuracy intra-operatively.

Conditions

Parkinson's Disease

Keywords

Deep brain stimulation surgery under general anesthesia; Deep brain stimulation target accuracy; Deep brain stimulation for Parkinsons's disease; Deep brain stimulation functional outcomes; Deep brain stimulation quality of life outcomes

Outcome Measures

Primary Outcomes (1)

• "Off" and "On" Medication Unified Parkinson's Disease Rating III Score (UPDRS)

  A movement disorders clinician who had completed the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) training performed prospective baseline and 6-month postoperative assessments of motor function using the MDS modified UPDRS III on patients during both off-medication (PD medications held for 12 h) and on-medication states. UPDRS III motor scores range from 0 (no motor function deficit) to 132 (highest motor function deficit). There were no subscales.

  pre-operatively and 6 months post-operatively

Secondary Outcomes (1)

• Parkinson's Disease Quality-39 Score (PDQ-39)

  pre-operatively and 6 months post-operatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected by CPT codes corresponding to bilateral DBS electrode placement placed under general anesthesia with Leksell sterotactic navigation, portable CT and without the use of microelectrode recordings (MER).

You may qualify if:

• Patient's who have undergone DBS surgery under general anesthesia without electrophysiology, utilizing a portable head CT scanner to verify accuracy intra-operatively.

You may not qualify if:

• Patient's who have undergone DBS surgery awake, without general anesthesia and with electrophysiology.

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead

Study Sites (1)

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

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Francisco A. Ponce, MD
• Organization: Barrow Neurlogical Institute / St. Joseph's Hosptial & Medical Center

602-406-3242

Study Officials

• Francisco A Ponce, MD

  BARROW NEUROLOGICAL INSTITUTE / SJHMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 28, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 1, 2016
• Results First Posted: November 25, 2015

Record last verified: 2015-12

Locations

US (1)