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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00998660
First received: October 12, 2009
Last updated: February 19, 2015
Last verified: February 2015
Results First Received: February 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Parkinson's Disease
Essential Tremor
Dystonia
Intervention: Device: Activa RC

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Patients Receiving an Activa RC Implant  
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dystonia Patients Implanted With the Activa RC Patients who were implanted with the Activa RC neurostimulator to treat dystonia.
Essential Tremor Patients Implanted With the Activa RC Patients who were implanted with the Activa RC neurostimulator to treat Essential Tremor.
Parkinsons Disease Patients Implanted With the Activa RC Patients who were implanted with the Activa RC neurostimulator to treat Parkinson's Disease.
Total Total of all reporting groups

Baseline Measures
    Dystonia Patients Implanted With the Activa RC     Essential Tremor Patients Implanted With the Activa RC     Parkinsons Disease Patients Implanted With the Activa RC     Total  
Number of Participants  
[units: participants]
  28     11     54     93  
Age  
[units: years]
Mean (Full Range)
  40.4  
  (11 to 82)  
  64.5  
  (39 to 79)  
  59.6  
  (39 to 79)  
  54.4  
  (11 to 82)  
Gender  
[units: participants]
       
Female     13     7     11     31  
Male     15     4     43     62  
Region of Enrollment  
[units: 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  



  Outcome Measures

1.  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.   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Todd Weaver, PhD
Organization: Medtronic, Inc.
phone: 763-526-8130
e-mail: todd.weaver@medtronic.com



Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00998660     History of Changes
Other Study ID Numbers: 1649
Study First Received: October 12, 2009
Results First Received: February 19, 2015
Last Updated: February 19, 2015
Health Authority: United States: Institutional Review Board
Germany: Technischer Überwachungsverein