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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

MedtronicNeuro

ClinicalTrials.gov Identifier:

NCT00998660

First received: October 12, 2009

Last updated: January 16, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2009

Last Updated Date

January 16, 2013

Start Date ^ICMJE

July 2009

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00998660 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Parkinson's Disease
Essential Tremor
Dystonia

Intervention ^ICMJE

Device: Activa RC

Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation

Study Arm (s)

Experimental: Patients receiving an Activa RC implant

Intervention: Device: Activa RC

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

7 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, France, Germany, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00998660

Other Study ID Numbers ^ICMJE

1649

Has Data Monitoring Committee

Responsible Party

MedtronicNeuro

Study Sponsor ^ICMJE

MedtronicNeuro

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

ISPR Team

Medtronic

Information Provided By

MedtronicNeuro

Verification Date

January 2013

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

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