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

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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.


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.
We found this trial at
3
sites
Miami, Florida 33176
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