RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease, Neurology, Orthopedic |
Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | July 2009 |
End Date: | July 2012 |
Contact: | ISPR Team |
Email: | medtronicneurotrials@medtronic.com |
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.
Inclusion Criteria:
- 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 Criteria:
- 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.
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