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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43NS081902 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| University of Cincinnati | OTHER |
The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders such as Parkinson's disease has been well established; however, there is a great disparity in outcomes among DBS recipients due to varied postoperative management, particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations. This study will evaluate the use of motion sensor based assessments to develop a functional map and algorithms to automatically determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated Programming | Experimental | Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated Programming | Device | Prototype DBS-Expert software will be used to guide a clinician through DBS programming. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming | Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline. | Within two days of standard clinical DBS programming session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dustin A Heldman, PhD | Great Lakes NeuroTechnologies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Department of Neurology | Cincinnati | Ohio | 45267 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26621764 | Result | Heldman DA, Pulliam CL, Urrea Mendoza E, Gartner M, Giuffrida JP, Montgomery EB Jr, Espay AJ, Revilla FJ. Computer-Guided Deep Brain Stimulation Programming for Parkinson's Disease. Neuromodulation. 2016 Feb;19(2):127-32. doi: 10.1111/ner.12372. Epub 2015 Dec 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Automated Programming | Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting. Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Automated Programming | Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting. Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming. |
| 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 | Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming | Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline. | Posted | Mean | Standard Deviation | Percentage change | Within two days of standard clinical DBS programming session |
|
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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 | Automated Programming | Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting. Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biomedical Research Manager | Great Lakes NeuroTechnologies Inc | 2163615410 | dheldman@glneurotech.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D014202 | Tremor |
| D018476 | Hypokinesia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |