N/A
N=17
IPG Replacement Study (PREFERENCE-H)
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT02963259 ↗Enrolled (actual)
17
Serious AEs
5.9%
Results posted
Jul 2024
Primary outcome: Primary: The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit. — 4 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit. |
4 | — |
| SECONDARY Number of Events Per Patient-year of Follow-up |
— | — |
| SECONDARY Incidence Rate |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject (and caregiver, if applicable) signed the approved Informed Consent;
- Subject is ≥ 18 and ≤ 74 years of age;
- Subject is bilaterally treated with deep brain stimulation (DBS) in the subthalamic nucleus (STN) using a constant voltage device (i.e. Soletra™, Itrel™, Kinetra™, ActivaPC™ or ActivaRC™ IPG) and is responding satisfactory to CV stimulation in the Investigator's opinion;
- In the physician's opinion, the subject is a suitable candidate for an IPG replacement with different stimulation paradigm;
- Subject needs and/or requests an IPG replacement within 12 months after consent and the current IPG has at least 2.6 V output left (i.e. approx. 30% of full battery capacity) at the time of subject enrollment;
- PD symptom onset is no longer than 20 years;
- Subject has a Hoehn & Yahr score 10 recurrent falls experienced in the 3 months prior to consent;
- Subject is unwilling to change to either a St Jude Medical Infinity™ or Brio™ DBS system for the IPG replacement;
- Subject is unable to attend the study visits.
Data sourced from ClinicalTrials.gov (NCT02963259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.