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

Parkinson's Disease Clinical Trial

— RECHARGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998660
• Other study ID #: 1649
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2009
• Last updated: February 19, 2015
• Start date: July 2009
• Est. completion date: July 2013

Study information

• Verified date: February 2015
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Technischer Überwachungsverein
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dystonia
• Essential Tremor
• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Subject-months of follow-up were defined as the time from device activation to the earlier of a subject's 3-month visit or until the subject exited from the study. Any user-related battery depletion adverse events requiring intervention by a health care professional (HCP) and/or the HCP's designee were collected. The event rate per 100 subject-months of follow-up is defined as the number of user-related battery depletion events divided by the total subject follow-up months through the 3-month visit, all multiplied by 100.	3 months	Yes