Clinical trial NCT00998660: RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
Official title: RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Essential Tremor
Dystonia
Keywords: Parkinson's disease
Essential Tremor
Dystonia (where indication is approved)
Deep brain stimulation
Activa RC
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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 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.

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
state: District of Columbia
city: Cincinnati
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Vienna
country: Austria
city: Montpellier
country: France
city: Cologne
country: Germany
city: Hannover
country: Germany
city: Barcelona
country: Spain
city: Oxford
country: United Kingdom
Study officials:
affiliation: Medtronic
name: ISPR Team
role: STUDY_CHAIR
References: