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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline frequency | No Intervention | Baseline DBS frequency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frequency change to 60 Hz | Procedure | 60 Hz stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Velocity | gait velocity measured as change from baseline in in CM/second | 5 hours |
| Time to Walk 14 Meters | Change in the time to walk 14 meters compared to baseline measured in seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fenna T Phibbs, MD | Vanderbilt Univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baseline Frequency | Gait analysis at the subjects baseline DBS frequency |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Frequency | Gait analysis at the subjects baseline DBS frequency |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Full Range | CM | 1 hour |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline Frequency | Gait analysis at the subjects baseline DBS frequency |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fenna Phibbs M.D. | Vanderbilt University | 615-936-2025 | fenna.phibbs@vanderbilt.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Frequency change to 130 Hz | Procedure | 130 Hz Stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion. |
|
|
| 5 hours |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Gait Velocity | gait velocity measured as change from baseline in in CM/second | Not Posted | 5 hours |
| Secondary | Time to Walk 14 Meters | Change in the time to walk 14 meters compared to baseline measured in seconds | Not Posted | 5 hours |
| 0 |
| 20 |
| 0 |
| 20 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |