IPG Replacement Study (PREFERENCE-H)

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 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.

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 <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.

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 Infinity™ or Brio™ DBS system for the IPG replacement;
• Subject is unable to attend the study visits.