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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00998660
First received: October 12, 2009
Last updated: July 9, 2013
Last verified: July 2013

October 12, 2009
July 9, 2013
July 2009
July 2013   (final data collection date for primary outcome 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. [ Time Frame: 1, 2, 3, and 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00998660 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Parkinson's Disease
  • Essential Tremor
  • Dystonia
Device: Activa RC
Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
Experimental: Patients receiving an Activa RC implant
Intervention: Device: Activa RC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   France,   Germany,   Spain,   United Kingdom
 
NCT00998660
1649
No
MedtronicNeuro
MedtronicNeuro
Not Provided
Study Chair: ISPR Team Medtronic
MedtronicNeuro
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP