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To evaluate DBS device settings and match with the features of the DBS care management software.
This is a study done on Parkinson disease subjects who have received the DBS system implanted in their subthalamic nucleus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's disease Subjects | Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system in the subthalamic nucleus (STN). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic DBS system | Device | Advanced Parkinson's disease patients implanted with the Medtronic Deep Brain Stimulation (DBS) system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap | The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores | The summary of UPDRS III medication off score at baseline and the UPDRS III stimulation on/medication off score at follow-up and the change from baseline to 18 months. The UPRS III has a range of 0 - 108. | Change from baseline to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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Parkinson's disease patients who have been implanted with the DBS system
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Pahwa, MD | Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center | Principal Investigator |
| Melissa Houser, MD | Scripps Clinic Division of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic, Division of Neurology | La Jolla | California | 92037 | United States | ||
| Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center |
Following enrollment but prior to analysis, MRIs were evaluated for readability. Those unreadable were excluded from analysis (N=3).
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| ID | Title | Description |
|---|---|---|
| FG000 | PD Patients Implanted With DBS System | Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus who consented for the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Advanced Parkinson's Disease | Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off. |
| 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 | To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap | The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study. | Per Protocol | Posted | Number | percentage of leads | 18 months | leads | leads |
|
|
No safety data collected
The protocol for the study did not include safety data collection
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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 | Subjects With Advanced Parkinson's Disease | The study protocol did not require safety data to be collected for the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Salisbury | Medtronic Neuromodulation | 763-526-8096 | stephanie.salisbury@medtronic.com |
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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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| Kansas City |
| Kansas |
| 66160 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| UPDRS III scores at baseline | Patients with documented improvement of UPDRS III scores of at least 35% were included in the study. A higher score means more motor dysfunction. The score can range from 0 -108. | Mean | Standard Deviation | units on a scale |
|
| Participants |
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| leads |
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|
|
| Secondary | Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores | The summary of UPDRS III medication off score at baseline and the UPDRS III stimulation on/medication off score at follow-up and the change from baseline to 18 months. The UPRS III has a range of 0 - 108. | Per protocol | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 18 months |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |