Parkinson Disease
Conditions
Keywords
Parkinson's Disease, DBS, Frequency, Deep brain stimulation
Brief summary
In this study the investigators will evaluate the effect of both low and high frequency Deep Brain stimulation of the subthalamic nucleus (STN) in Parkinson's patients who have noted a change in their walking. The investigators' hypothesis is: 1. Stimulation at 60 Hertz (Hz) is associated with improved gait with increased stride length and faster time on the Stand walk sit test. 2. There is no worsening of the Unified Parkinson's Disease Rating Scale (UPDRS) at 60 Hz.
Interventions
PROCEDUREFrequency change to 60 Hz
60 Hz stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
PROCEDUREFrequency change to 130 Hz
130 Hz Stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
Sponsors
Vanderbilt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Be a patient at the Vanderbilt Movement Disorders clinic. * Report a change in their gait. * Be able to walk independently when off PD medications for 12-16 hours. * Have a stable dose of PD medications for the prior three months . * Not cognitively impaired, so as to give informed consent. * MMSE \> 24.
Exclusion criteria
* See inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stride Length From Baseline | 1 hour | Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Velocity | 5 hours | gait velocity measured as change from baseline in in CM/second |
| Time to Walk 14 Meters | 5 hours | Change in the time to walk 14 meters compared to baseline measured in seconds |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Frequency Gait analysis at the subjects baseline DBS frequency | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Baseline Frequency |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age Continuous | 62 years STANDARD_DEVIATION 5.54 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Change in Stride Length From Baseline
Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length
Time frame: 1 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline Frequency | Change in Stride Length From Baseline | 1.19 CM |
Secondary
Gait Velocity
gait velocity measured as change from baseline in in CM/second
Time frame: 5 hours
Secondary
Time to Walk 14 Meters
Change in the time to walk 14 meters compared to baseline measured in seconds
Time frame: 5 hours