Trial Outcomes & Findings for DBS Under General Anesthesia: Comparison To The Standard Technique (NCT NCT01997398)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

35 participants

Primary outcome timeframe

pre-operatively and 6 months post-operatively

Results posted on

2016-01-01

Participant Flow

All consecutive Parkinson's disease (PD) patients undergoing bilateral GPi deep brain stimulation surgery (DBS) under general anesthesia from May, 2012 - November of 2013.

Patients with advanced Parkinson's disease eligible for deep brain stimulation (DBS) surgery

Participant milestones

Participant milestones
Measure	Bilateral GPi DBS Surgery Under General Anesthesia Patients underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
Overall Study STARTED	35
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DBS Under General Anesthesia: Comparison To The Standard Technique

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DBS Under General Anesthesia n=35 Participants Patients with advanced Parkinson's disease who underwent bilateral globus pallidus interna (GPi) deep brain stimulation surgery under general anesthesia without the use of microelectrode recordings or intraoperative stimulation.
Age, Continuous	61.1 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Average duration of Parkinson's disease	10.7 years STANDARD_DEVIATION 10 • n=5 Participants

PRIMARY outcome

Timeframe: pre-operatively and 6 months post-operatively

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.

Outcome measures

Outcome measures
Measure	Pre-DBS Bilateral GPi DBS Under General Anesthesia "Off" Med n=35 Participants "Off " medication UPDRS III scores of patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy. Off medication .	Post-DBS Bilateral GPi DBS Under General Anesthesia "Off" Med n=34 Participants "Off" medication UPDRS III scores of patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.	Pre-DBS Bilateral GPi DBS Under General Anesthesia "On" Med n=35 Participants "On" medication scores of patients scheduled for bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.	Post-DBS Bilateral GPi DBS Under General Anesthesia "On" Med n=34 Participants "On" medication scores of patients who underwent bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
"Off" and "On" Medication Unified Parkinson's Disease Rating III Score (UPDRS)	48.4 units on a scale Standard Deviation 13.8	28.9 units on a scale Standard Deviation 12.5	23.52 units on a scale Standard Deviation 10.4	22.56 units on a scale Standard Deviation 12.8

SECONDARY outcome

Timeframe: pre-operatively and 6 months post-operatively

Effects on PDQ-39 scores 6 months following asleep DBS surgery as compared to pre-operative scores. Data from the PDQ-39 can be presented either subset scores or as a single total score. PDQ-39 measures patient quality of life indicators including mobility, activities of daily living, emotional well being, stigma, communication and bodily discomfort. Data from the PDQ-39 can be presented in either subset scores or as a single total score. The full range of the total PDQ-39 scores is from 0 ( no patient related symptoms, or quality of life unaffected) to 156 ( relates having symptoms ", or low quality of life). The subset score ranges are as follows: mobility: 0 (no patient related symptoms) to 40 (highest patient related symptoms). activities of daily living: 0 to 24; emotional well being: 0-24; stigma: 0-16; cognition: 0-16; communication: 0-12; bodily discomfort: 0-12.

Outcome measures

Outcome measures
Measure	Pre-DBS Bilateral GPi DBS Under General Anesthesia "Off" Med n=35 Participants "Off " medication UPDRS III scores of patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy. Off medication .	Post-DBS Bilateral GPi DBS Under General Anesthesia "Off" Med n=34 Participants "Off" medication UPDRS III scores of patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.	Pre-DBS Bilateral GPi DBS Under General Anesthesia "On" Med "On" medication scores of patients scheduled for bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.	Post-DBS Bilateral GPi DBS Under General Anesthesia "On" Med "On" medication scores of patients who underwent bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
Parkinson's Disease Quality-39 Score (PDQ-39)	50.3 units on a scale Standard Deviation 20.7	42.0 units on a scale Standard Deviation 23.6	—	—

Adverse Events

Bilateral GPi DBS Surgery Under General Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Francisco A. Ponce, MD

Barrow Neurlogical Institute / St. Joseph's Hosptial & Medical Center

Phone: 602-406-3242

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place