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The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on walking in patients with Parkinson's disease that have had DBS. While DBS improves Parkinson's disease (PD) symptoms and walking in many patients in some of the patients walking problems persist. This study aims to find out what are the best stimulation parameters of the DBS in order to improve walking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral stimulation | Experimental | Participants will receive Deep Brain Stimulation Bilaterally. |
|
| Left stimulation | Experimental | Participants will receive Deep Brain Stimulation on the left side only |
|
| Right stimulation | Experimental | Participants will receive Deep Brain Stimulation on the right side only |
|
| Off stimulation | No Intervention | Participants will receive no brain stimulation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulator | Device | DBS will provide brain stimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Walking Speed | Walking speed will be measured using sensors reported in meter per second. | Up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Stride Length | Stride length will be measured using sensors and will be reported in meters. | Up to 1 hour |
| UPDRS Scores | Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corneliu Luca, MD, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants that completed the 4 arm crossover study design |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Walking Speed | Walking speed will be measured using sensors reported in meter per second. | All participants completed all 4 arms in the cross over study design. | Posted | Mean | Standard Deviation | meter per second | Up to 1 hour |
|
Up to 7 hours
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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 | Bilateral Stimulation | Participants will receive Deep Brain Stimulation Bilaterally. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corneliu Luca, MD, PhD | University of Miami | 305-243-6732 | cluca@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2016 | Mar 3, 2021 | Prot_SAP_000.pdf |
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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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| Up to 1 hour |
| TUG Test | 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. | Up to 1 hour |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants will receive Deep Brain Stimulation on the right side only |
| OG003 | OFF Stimulation | Participants will receive no Deep Brain Stimulation |
|
|
| Secondary | Stride Length | Stride length will be measured using sensors and will be reported in meters. | all participants completed all 4 arms in the crossover study design. | Posted | Mean | Standard Deviation | meters | Up to 1 hour |
|
|
|
| Secondary | UPDRS Scores | Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition. | All participants completed all 4 arms in the crossover study design | Posted | Mean | Standard Deviation | score on a scale | Up to 1 hour |
|
|
|
| Secondary | TUG Test | 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. | 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. | Posted | Up to 1 hour |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Left Stimulation | Participants will receive Deep Brain Stimulation on the left side only | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Right Stimulation | Participants will receive Deep Brain Stimulation on the right side only | 0 | 22 | 0 | 22 | 0 | 22 |
| EG003 | OFF Stimulation | Participants will receive no Deep Brain Stimulation | 0 | 22 | 0 | 22 | 0 | 22 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |