Dystonia, Essential Tremor, Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Essential Tremor, Dystonia (where indication is approved), Deep brain stimulation, Activa RC
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.
Interventions
DEVICEActiva RC
Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
Sponsors
MedtronicNeuro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 months | 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. |
Countries
Austria, France, Germany, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dystonia Patients Implanted With the Activa RC Patients who were implanted with the Activa RC neurostimulator to treat dystonia. | 28 |
| Essential Tremor Patients Implanted With the Activa RC Patients who were implanted with the Activa RC neurostimulator to treat Essential Tremor. | 11 |
| Parkinsons Disease Patients Implanted With the Activa RC Patients who were implanted with the Activa RC neurostimulator to treat Parkinson's Disease. | 54 |
| Total | 93 |
Baseline characteristics
| Characteristic | Parkinsons Disease Patients Implanted With the Activa RC | Total | Dystonia Patients Implanted With the Activa RC | Essential Tremor Patients Implanted With the Activa RC |
|---|---|---|---|---|
| Age, Continuous | 59.6 years | 54.4 years | 40.4 years | 64.5 years |
| Region of Enrollment Austria | 4 participants | 9 participants | 5 participants | 0 participants |
| Region of Enrollment France | 0 participants | 15 participants | 15 participants | 0 participants |
| Region of Enrollment Germany | 10 participants | 17 participants | 6 participants | 1 participants |
| Region of Enrollment Spain | 1 participants | 2 participants | 1 participants | 0 participants |
| Region of Enrollment United Kingdom | 4 participants | 5 participants | 1 participants | 0 participants |
| Region of Enrollment United States | 35 participants | 45 participants | 0 participants | 10 participants |
| Sex: Female, Male Female | 11 Participants | 31 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 43 Participants | 62 Participants | 15 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 93 |
| serious Total, serious adverse events | 9 / 93 |
Outcome results
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.
Time frame: 3 months
Population: The 93 implanted subjects accumulated 283.6 subject-months of follow-up through the 3-month visit. There were no reported user-related battery depletion adverse events that required an intervention by a health care professional and/or HCP designee.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Implanted With the Activa RC | 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. | 0.00 Event rate per 100 subject-months |