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

Medtronic

Status and phase: Completed; Phase 4

Conditions: Essential Tremor; Dystonia; Parkinson's Disease

Treatments: Device: Activa RC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00998660

1649

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Patients receiving an Activa RC implant

Experimental group

Treatment:

Device: Activa RC