Trial Outcomes & Findings for Clinical Outcomes of Deep Brain Stimulator (DBS) Electrodes Placed Using Intraoperative Computed Tomography (CT) and Frameless Stereotaxis (NCT NCT01703598)

Results Overview

Change in motor UPDRS in OFF Levodopa state. The range of this outcome is from 0 to 108, a higher number indicated a worse clinical state. The number represents units on this scale.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

69 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2019-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	DBS Surgery Single arm Deep Brain Stimulation: Placement of Deep Brain Stimulation electrodes DBS surgery: Placement of DBS electrodes
Overall Study STARTED	69
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DBS Surgery n=69 Participants Single arm Deep Brain Stimulation: Placement of Deep Brain Stimulation electrodes DBS surgery: Placement of DBS electrodes
Age, Continuous	63.1 years STANDARD_DEVIATION 7.61 • n=69 Participants
Sex: Female, Male Female	23 Participants n=69 Participants
Sex: Female, Male Male	46 Participants n=69 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Change in motor UPDRS in OFF Levodopa state. The range of this outcome is from 0 to 108, a higher number indicated a worse clinical state. The number represents units on this scale.

Outcome measures

Outcome measures
Measure	DBS Surgery n=69 Participants Single arm Deep Brain Stimulation: Placement of Deep Brain Stimulation electrodes DBS surgery: Placement of DBS electrodes
Change in Motor OFF Ldopa UPDRS	14.8 motor UPDRS Standard Deviation 8.9

Adverse Events

DBS Surgery

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

Matthew Brodsky MD

Oregon Health & Science University

Phone: 503-494-9054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place