IPG Replacement Study (PREFERENCE-H)
Completed
Conditions studied: Parkinson Disease
In brief
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.
Key facts
- Study ID
- NCT02963259
- Run by
- Abbott Medical Devices
- People needed
- 17
- Starts
- 2017-03-29
- Expected to finish
- 2020-01-31
- Last updated by the study team
- 2024-07-08
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 <IV (on stim);
- Subject with a normal cognitive function (MMSE ≥25);
- Subject is fluent speaker (as judged by the investigator) of the language spoken in the country where the investigational site is located.
You may not qualify if…
- IPG battery has less than 30% battery life at the time of consent;
- Need to replace or reposition the leads or extensions during the IPG replacement procedure;
- Subject had >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.
Where it is running
- Baptist Hospital of Miami — Kendall, Florida, United States
- Neuroscience Consultants — Miami, Florida, United States
- Albany Medical College at Albany Medical Ctr — Albany, New York, United States
- Praxis Dr. Oehlwein — Gera, Germany
- Klinik am Tharandter Wald — Halsbrücke, Germany
- Universitätsklinikum Leipzig AÖR — Leipzig, Germany
- Az.Osp. Universitaria Ferrara — Ferrara, Cona, Italy
- Fondazione "Ospedale San Camillo" I.R.C.C.S — Padua, Veneto, Italy
- Ospedale Generale Regionale F. Miulli — Acquaviva delle Fonti, Italy
- Ospedale dell'Angelo — Mestre, Italy
- IRCCS Istituto Ortopedico Galeazzi — Milan, Italy
- Fondazione Istituto Neurologico Nazionale C. Mondino — Pavia, Italy
- Policlinico Universitario A. Gemelli — Roma, Italy
- Azienda Ospedaliero-Universitaria S Maria della Misericordia — Udine, Italy
Full record on ClinicalTrials.gov
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