Trial Outcomes & Findings for Deep Brain Stimulation (DBS) Frequency Effects on Gait in Parkinson's Disease(PD) (NCT NCT00993291)

NCT ID: NCT00993291

Last Updated: 2012-01-27

Results Overview

Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2012-01-27

Participant Flow

Participant milestones

Measure	Baseline Frequency Gait analysis at the subjects baseline DBS frequency
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Baseline Frequency Gait analysis at the subjects baseline DBS frequency
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Deep Brain Stimulation (DBS) Frequency Effects on Gait in Parkinson's Disease(PD)

Baseline characteristics by cohort

Measure	Baseline Frequency n=20 Participants Gait analysis at the subjects baseline DBS frequency
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age Continuous	62 years STANDARD_DEVIATION 5.54 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length

Outcome measures

Measure	Baseline Frequency n=20 Participants Gait analysis at the subjects baseline DBS frequency
Change in Stride Length From Baseline	1.19 CM Interval -183.0 to 37.0

SECONDARY outcome

Timeframe: 5 hours

gait velocity measured as change from baseline in in CM/second

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 hours

Change in the time to walk 14 meters compared to baseline measured in seconds

Outcome measures

Outcome data not reported

Adverse Events

Baseline Frequency

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

Fenna Phibbs M.D.

Vanderbilt University

Phone: 615-936-2025

Email: fenna.phibbs@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place