Trials / Completed
CompletedNCT02963259
IPG Replacement Study (PREFERENCE-H)
Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 17 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
This post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical Infinity™ or St Jude Medical Brio™ constant current system. As electrodes will not be re-positioned, differences in subject's preference are to be explained by the difference in shape of the delivered pulse or waveform between the two systems.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system | Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system |
Timeline
- Start date
- 2017-03-29
- Primary completion
- 2019-11-29
- Completion
- 2020-01-31
- First posted
- 2016-11-15
- Last updated
- 2024-07-08
- Results posted
- 2024-07-08
Locations
14 sites across 3 countries: United States, Germany, Italy
Source: ClinicalTrials.gov record NCT02963259. Inclusion in this directory is not an endorsement.