Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00998660
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT00998660
Study Brief:
Protocol Section:
NCT00998660