IPG Replacement Study (PREFERENCE-H)
Status: | Recruiting |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 74 |
Updated: | 2/3/2019 |
Start Date: | March 30, 2017 |
End Date: | December 2020 |
Contact: | Nicole Harbert |
Email: | nicole.harbert@abbott.com |
Phone: | +1 972 526 4841 |
Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems
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 BrioTM 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.
preference when switching from a Medtronic® constant voltage or constant current device to a
St Jude Medical Infinity™ or St Jude Medical BrioTM 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.
Inclusion Criteria:
- Subject 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 in the Investigator's opinion, is responding
satisfactory to CV stimulation;
- 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
- 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.
Exclusion Criteria:
- 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 InfinityTM or a St Jude
Medical BrioTM DBS system for the IPG replacement;
- Subject is unable to attend the study visits.
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