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The purpose of this study is to assess the recharge feature of the Activa RC System in patients who are receiving Deep Brain Stimulation (DBS) for Parkinson's Disease (PD), Essential Tremor (ET), or dystonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving an Activa RC implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activa RC | Device | Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identify the Rate of User-related Battery Depletion Adverse Events Per Subject-month Requiring Intervention by a Health Care Professional (HCP) and/or the HCP's Designee, Within the First 3 Months of the Activa RC System Being Turned ON. | Subject-months of follow-up were defined as the time from device activation to the earlier of a subject's 3-month visit or until the subject exited from the study. Any user-related battery depletion adverse events requiring intervention by a health care professional (HCP) and/or the HCP's designee were collected. The event rate per 100 subject-months of follow-up is defined as the number of user-related battery depletion events divided by the total subject follow-up months through the 3-month visit, all multiplied by 100. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ISPR Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington D.C. | District of Columbia | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Receiving an Activa RC Implant | Activa RC: Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dystonia Patients Implanted With the Activa RC | Patients who were implanted with the Activa RC neurostimulator to treat dystonia. |
| BG001 | Essential Tremor Patients Implanted With the Activa RC |
| 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 | Identify the Rate of User-related Battery Depletion Adverse Events Per Subject-month Requiring Intervention by a Health Care Professional (HCP) and/or the HCP's Designee, Within the First 3 Months of the Activa RC System Being Turned ON. | Subject-months of follow-up were defined as the time from device activation to the earlier of a subject's 3-month visit or until the subject exited from the study. Any user-related battery depletion adverse events requiring intervention by a health care professional (HCP) and/or the HCP's designee were collected. The event rate per 100 subject-months of follow-up is defined as the number of user-related battery depletion events divided by the total subject follow-up months through the 3-month visit, all multiplied by 100. | The 93 implanted subjects accumulated 283.6 subject-months of follow-up through the 3-month visit. There were no reported user-related battery depletion adverse events that required an intervention by a health care professional and/or HCP designee. | Posted | Number | 95% Confidence Interval | Event rate per 100 subject-months | 3 months |
|
Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).
The occurrence of adverse events was assessed by the investigator at each study visit. All adverse events, regardless of relatedness to the device and/or therapy, were collected. Within the 93 implanted subjects, there was 560.4 months of study follow-up from Activa RC implant to study discontinuation.
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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 | Patients Implanted With the Activa RC | All enrolled patients implanted with the Activa RC neurostimulator. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyskinesia | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
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Potential limitations of the study include the limited sample size to fully characterize recharge use by indication. In addition, inferences to a broader population should also be limited given the relatively short duration of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Weaver, PhD | Medtronic, Inc. | 763-526-8130 | todd.weaver@medtronic.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020329 | Essential Tremor |
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Cincinnati |
| Ohio |
| United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| Tyler | Texas | 75701 | United States |
| Vienna | Austria |
| Montpellier | France |
| Cologne | Germany |
| Hanover | Germany |
| Barcelona | Spain |
| Oxford | United Kingdom |
Patients who were implanted with the Activa RC neurostimulator to treat Essential Tremor.
| BG002 | Parkinsons Disease Patients Implanted With the Activa RC | Patients who were implanted with the Activa RC neurostimulator to treat Parkinson's Disease. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Patients Implanted With the Activa RC | All enrolled patients implanted with the Activa RC neurostimulator. |
|
|
| 9 |
| 93 |
| 0 |
| 93 |
| Concussion | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| Implant site infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Implant site inflammation | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| Implant site pain | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
Sponsor will review results communications prior to public release to determine whether Confidential Information is disclosed and will not censor or in any way interfere with presentation or conclusions beyond the extent necessary to protect Confidential Information. PIs are required to provide results communications for review at least 60 days prior to submission or presentation. When requested by Sponsor, PI will delay publication up to an additional 90 days.
| 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 |