Status:
COMPLETED
RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
Lead Sponsor:
MedtronicNeuro
Conditions:
Parkinson's Disease
Essential Tremor
Eligibility:
All Genders
7+ years
Phase:
PHASE4
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- Patient is enrolled in the Implantable Systems Performance Registry (ISPR) and will receive one Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for DBS.
- Patient must meet the indications in the Activa RC labeling.
- Patient (or patient's legally authorized representative) signs and dates the appropriate RECHARGE Informed Consent Form and/or Informed Assent Form and Authorization to Use and Disclose Health Information (HIPAA, US only).
- Patient has a diagnosis of Parkinson's Disease, Essential Tremor, or dystonia that meets the approved indication for Activa RC in the applicable geography.
- Patient with dystonia is 7 years of age or older (EU only).
- Patient with either PD or ET is 18 years of age or older.
- Patient (or caregiver) is able to use the patient programmer and correctly interpret the icons.
- Patient (or caregiver) is able and willing to regularly monitor the status of the rechargeable battery and respond appropriately.
- Patient (or caregiver) is able to locate the INS, position the recharge antenna for sufficient coupling, put on the recharge holster/belt, and monitor progress during the recharge session.
- Patient (or caregiver) is able to perform recharging activities for sufficient duration and frequency to maintain therapy and to perform recharging activities on an ongoing basis.
- Patient is willing and able to comply with protocol requirements.
Exclusion
- Patient has a contraindication identified in the Activa RC labeling.
- Patient who is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of the RECHARGE study.
- Patient has or will be implanted with a non-Medtronic Deep Brain Stimulation system component.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00998660
Start Date
July 1 2009
End Date
July 1 2013
Last Update
March 6 2015
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington D.C., District of Columbia, United States
2
Cincinnati, Ohio, United States
3
Nashville, Tennessee, United States
4
Houston, Texas, United States