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

NCT00998660 | Completed Phase 4 Results

• 1 other identifier: 1649
• Study Type: interventional
• Target: 100
• Locations: 6 countries
• Sites: 11

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.

Conditions

Parkinson's Disease; Essential Tremor; Dystonia

Keywords

Parkinson's disease; Essential Tremor; Dystonia (where indication is approved); Deep brain stimulation; Activa RC

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients receiving an Activa RC implant

EXPERIMENTAL

Device: Activa RC

Interventions

Activa RC DEVICE

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

Patients receiving an Activa RC implant

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (11)

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Tyler, Texas, 75701, United States

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Montpellier, France

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Dystonia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Potential limitations of the study include the limited sample size to fully characterize recharge use by indication. In addition, inferences to a broader population should also be limited given the relatively short duration of the study.

Results Point of Contact

• Title: Todd Weaver, PhD
• Organization: Medtronic, Inc.

todd.weaver@medtronic.com

763-526-8130

Study Officials

• ISPR Team

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2009
• First Posted: October 20, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 6, 2015
• Results First Posted: March 6, 2015

Record last verified: 2015-02

Locations

GB (1); ES (1); FR (1); US (5); DE (2); AU (1)