Trial Outcomes & Findings for Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease (NCT NCT02022735)

NCT ID: NCT02022735

Last Updated: 2021-05-28

Results Overview

Walking speed will be measured using sensors reported in meter per second.

Recruitment status

TERMINATED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Up to 1 hour

Results posted on

2021-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All participants enrolled in the study completed the 4 arms crossover study design. All participants received and was evaluated for all four interventions: Bilateral Deep Brain Stimulation (DBS), Right Side DBS, Left side DBS and Off/No Stimulation.
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=22 Participants All participants that completed the 4 arm crossover study design
Age, Continuous	65 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 hour

Population: All participants completed all 4 arms in the cross over study design.

Walking speed will be measured using sensors reported in meter per second.

Outcome measures

Outcome measures
Measure	Bilateral Stimulation n=22 Participants Participants will receive Deep Brain Stimulation Bilaterally.	Left Stimulation n=22 Participants Participants will receive Deep Brain Stimulation on the left side only	Right Stimulation n=22 Participants Participants will receive Deep Brain Stimulation on the right side only	OFF Stimulation n=22 Participants Participants will receive no Deep Brain Stimulation
Walking Speed	0.95 meter per second Standard Deviation 0.05	0.90 meter per second Standard Deviation 0.05	0.92 meter per second Standard Deviation 0.05	0.84 meter per second Standard Deviation 0.07

SECONDARY outcome

Timeframe: Up to 1 hour

Population: all participants completed all 4 arms in the crossover study design.

Stride length will be measured using sensors and will be reported in meters.

Outcome measures

Outcome measures
Measure	Bilateral Stimulation n=22 Participants Participants will receive Deep Brain Stimulation Bilaterally.	Left Stimulation n=22 Participants Participants will receive Deep Brain Stimulation on the left side only	Right Stimulation n=22 Participants Participants will receive Deep Brain Stimulation on the right side only	OFF Stimulation n=22 Participants Participants will receive no Deep Brain Stimulation
Stride Length	1.09 meters Standard Deviation 0.04	1.01 meters Standard Deviation 0.05	1.06 meters Standard Deviation 0.04	0.95 meters Standard Deviation 0.06

SECONDARY outcome

Timeframe: Up to 1 hour

Population: All participants completed all 4 arms in the crossover study design

Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition.

Outcome measures

Outcome measures
Measure	Bilateral Stimulation n=22 Participants Participants will receive Deep Brain Stimulation Bilaterally.	Left Stimulation n=22 Participants Participants will receive Deep Brain Stimulation on the left side only	Right Stimulation n=22 Participants Participants will receive Deep Brain Stimulation on the right side only	OFF Stimulation n=22 Participants Participants will receive no Deep Brain Stimulation
UPDRS Scores	24.09 score on a scale Standard Deviation 2.76	38.36 score on a scale Standard Deviation 3.52	35.59 score on a scale Standard Deviation 3.19	48.68 score on a scale Standard Deviation 3.41

SECONDARY outcome

Timeframe: Up to 1 hour

Population: Team member with access to TUG score data analysis has left the institution. PI was not given access to retrieve data prior to study team member leaving the institution.

Time Up and Go (TUG) Test reports the time it takes for participant to stand up from chair, walk around a cone and return to chair.

Outcome measures

Outcome data not reported

Adverse Events

Bilateral Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Left Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Right Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OFF Stimulation

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

Corneliu Luca, MD, PhD

University of Miami

Phone: 305-243-6732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place