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
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Essential Tremor
Dystonia
Device: Activa RC
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: July 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients receiving an Activa RC implant Device: Activa RC
Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998660

Locations
United States, District of Columbia
Washington, District of Columbia, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
Tyler, Texas, United States, 75701
Austria
Vienna, Austria
France
Montpellier, France
Germany
Cologne, Germany
Hannover, Germany
Spain
Barcelona, Spain
United Kingdom
Oxford, United Kingdom
Sponsors and Collaborators
MedtronicNeuro
Investigators
Study Chair: ISPR Team Medtronic
  More Information

No publications provided

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00998660     History of Changes
Other Study ID Numbers: 1649
Study First Received: October 12, 2009
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board
Germany: Technischer Überwachungsverein

Keywords provided by MedtronicNeuro:
Parkinson's disease
Essential Tremor
Dystonia (where indication is approved)
Deep brain stimulation
Activa RC

Additional relevant MeSH terms:
Parkinson Disease
Dystonia
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014