RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
This study is ongoing, but not recruiting participants.
Sponsor:
MedtronicNeuro
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00998660
First received: October 12, 2009
Last updated: January 16, 2013
Last verified: January 2013
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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:
Genetics Home Reference related topics:
dopa-responsive dystonia
early-onset primary dystonia
essential tremor
Parkinson disease
Perry syndrome
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated 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
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: | January 16, 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:
|
Dystonia Dystonic Disorders Parkinson Disease Tremor Essential Tremor Dyskinesias Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Movement Disorders Central Nervous System Diseases Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on June 18, 2013