Phase 4
N=100
RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
Parkinson's Disease · Essential Tremor · Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT00998660 ↗Enrolled (actual)
100
Serious AEs
9.7%
Results posted
Mar 2015
Primary outcome: 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. — 0.00 Event rate per 100 subject-months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Activa RC (Device)
- Age
- Pediatric, Adult, Older Adult · 7+ yrs
- Sex
- All
- Sponsor
- MedtronicNeuro
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
0.00 | — |
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 dystonia.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00998660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.