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RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR) (RECHARGE)

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ClinicalTrials.gov Identifier: NCT00998660
Recruitment Status : Completed
First Posted : October 20, 2009
Results First Posted : March 6, 2015
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions Parkinson's Disease
Essential Tremor
Dystonia
Intervention Device: Activa RC
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients Receiving an Activa RC Implant
Hide Arm/Group Description Activa RC: Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
Period Title: Overall Study
Started 100
Implanted 93
Month 3 Visit 87
Completed 87 [1]
Not Completed 13
[1]
87 subjects reached the final study visit at Month 6.
Arm/Group Title Dystonia Patients Implanted With the Activa RC Essential Tremor Patients Implanted With the Activa RC Parkinsons Disease Patients Implanted With the Activa RC Total
Hide Arm/Group Description Patients who were implanted with the Activa RC neurostimulator to treat dystonia. Patients who were implanted with the Activa RC neurostimulator to treat Essential Tremor. Patients who were implanted with the Activa RC neurostimulator to treat Parkinson's Disease. Total of all reporting groups
Overall Number of Baseline Participants 28 11 54 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants 11 participants 54 participants 93 participants
40.4
(11 to 82)
64.5
(39 to 79)
59.6
(39 to 79)
54.4
(11 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 11 participants 54 participants 93 participants
Female
13
  46.4%
7
  63.6%
11
  20.4%
31
  33.3%
Male
15
  53.6%
4
  36.4%
43
  79.6%
62
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 11 participants 54 participants 93 participants
United States 0 10 35 45
France 15 0 0 15
Spain 1 0 1 2
Austria 5 0 4 9
Germany 6 1 10 17
United Kingdom 1 0 4 5
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Patients Implanted With the Activa RC
Hide Arm/Group Description:
All enrolled patients implanted with the Activa RC neurostimulator.
Overall Number of Participants Analyzed 93
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event rate per 100 subject-months
0.00
(0.00 to 1.30)
Time Frame Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).
Adverse Event Reporting Description 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.
 
Arm/Group Title Patients Implanted With the Activa RC
Hide Arm/Group Description All enrolled patients implanted with the Activa RC neurostimulator.
All-Cause Mortality
Patients Implanted With the Activa RC
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients Implanted With the Activa RC
Affected / at Risk (%) # Events
Total   9/93 (9.68%)    
General disorders   
Implant site inflammation  1  1/93 (1.08%)  1
Implant site pain  1  1/93 (1.08%)  1
Infections and infestations   
Implant site infection  1  1/93 (1.08%)  1
Staphylococcal infection  1  1/93 (1.08%)  1
Injury, poisoning and procedural complications   
Concussion  1  1/93 (1.08%)  1
Lower limb fracture  1  1/93 (1.08%)  1
Wound dehiscence  1  1/93 (1.08%)  1
Nervous system disorders   
Dyskinesia  1  2/93 (2.15%)  2
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/93 (1.08%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Implanted With the Activa RC
Affected / at Risk (%) # Events
Total   0/93 (0.00%)    
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Todd Weaver, PhD
Organization: Medtronic, Inc.
Phone: 763-526-8130
EMail: todd.weaver@medtronic.com
Layout table for additonal information
Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00998660     History of Changes
Other Study ID Numbers: 1649
First Submitted: October 12, 2009
First Posted: October 20, 2009
Results First Submitted: February 19, 2015
Results First Posted: March 6, 2015
Last Update Posted: March 6, 2015