Trial Outcomes & Findings for RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR) (NCT NCT00998660)
NCT ID: NCT00998660
Last Updated: 2015-03-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
3 months
Results posted on
2015-03-06
Participant Flow
Participant milestones
| Measure |
Patients Receiving an Activa RC Implant
Activa RC: Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
Implanted
|
93
|
|
Overall Study
Month 3 Visit
|
87
|
|
Overall Study
COMPLETED
|
87
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
Baseline characteristics by cohort
| Measure |
Dystonia Patients Implanted With the Activa RC
n=28 Participants
Patients who were implanted with the Activa RC neurostimulator to treat dystonia.
|
Essential Tremor Patients Implanted With the Activa RC
n=11 Participants
Patients who were implanted with the Activa RC neurostimulator to treat Essential Tremor.
|
Parkinsons Disease Patients Implanted With the Activa RC
n=54 Participants
Patients who were implanted with the Activa RC neurostimulator to treat Parkinson's Disease.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.4 years
n=5 Participants
|
64.5 years
n=7 Participants
|
59.6 years
n=5 Participants
|
54.4 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
10 participants
n=7 Participants
|
35 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
Region of Enrollment
France
|
15 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Patients Implanted With the Activa RC
n=93 Participants
All enrolled patients implanted with the Activa RC neurostimulator.
|
|---|---|
|
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
Interval 0.0 to 1.3
|
Adverse Events
Patients Implanted With the Activa RC
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients Implanted With the Activa RC
n=93 participants at risk
All enrolled patients implanted with the Activa RC neurostimulator.
|
|---|---|
|
Nervous system disorders
Dyskinesia
|
2.2%
2/93 • Number of events 2 • Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).
The occurrence of adverse events was assessed by the investigator at each study visit. All adverse events, regardless of relatedness to the device and/or therapy, were collected. Within the 93 implanted subjects, there was 560.4 months of study follow-up from Activa RC implant to study discontinuation.
|
|
Injury, poisoning and procedural complications
Concussion
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).
The occurrence of adverse events was assessed by the investigator at each study visit. All adverse events, regardless of relatedness to the device and/or therapy, were collected. Within the 93 implanted subjects, there was 560.4 months of study follow-up from Activa RC implant to study discontinuation.
|
|
Infections and infestations
Implant site infection
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).
The occurrence of adverse events was assessed by the investigator at each study visit. All adverse events, regardless of relatedness to the device and/or therapy, were collected. Within the 93 implanted subjects, there was 560.4 months of study follow-up from Activa RC implant to study discontinuation.
|
|
General disorders
Implant site inflammation
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).
The occurrence of adverse events was assessed by the investigator at each study visit. All adverse events, regardless of relatedness to the device and/or therapy, were collected. Within the 93 implanted subjects, there was 560.4 months of study follow-up from Activa RC implant to study discontinuation.
|
|
General disorders
Implant site pain
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).
The occurrence of adverse events was assessed by the investigator at each study visit. All adverse events, regardless of relatedness to the device and/or therapy, were collected. Within the 93 implanted subjects, there was 560.4 months of study follow-up from Activa RC implant to study discontinuation.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).
The occurrence of adverse events was assessed by the investigator at each study visit. All adverse events, regardless of relatedness to the device and/or therapy, were collected. Within the 93 implanted subjects, there was 560.4 months of study follow-up from Activa RC implant to study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).
The occurrence of adverse events was assessed by the investigator at each study visit. All adverse events, regardless of relatedness to the device and/or therapy, were collected. Within the 93 implanted subjects, there was 560.4 months of study follow-up from Activa RC implant to study discontinuation.
|
|
Infections and infestations
Staphylococcal infection
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).
The occurrence of adverse events was assessed by the investigator at each study visit. All adverse events, regardless of relatedness to the device and/or therapy, were collected. Within the 93 implanted subjects, there was 560.4 months of study follow-up from Activa RC implant to study discontinuation.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).
The occurrence of adverse events was assessed by the investigator at each study visit. All adverse events, regardless of relatedness to the device and/or therapy, were collected. Within the 93 implanted subjects, there was 560.4 months of study follow-up from Activa RC implant to study discontinuation.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor will review results communications prior to public release to determine whether Confidential Information is disclosed and will not censor or in any way interfere with presentation or conclusions beyond the extent necessary to protect Confidential Information. PIs are required to provide results communications for review at least 60 days prior to submission or presentation. When requested by Sponsor, PI will delay publication up to an additional 90 days.
- Publication restrictions are in place
Restriction type: OTHER