IPG Replacement Study (PREFERENCE-H)

Abbott

Status

Completed

Conditions

Parkinson Disease

Treatments

Device: SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system

Study type

Observational

Funder types

Industry

Identifiers

NCT02963259

SJM-CIP-10135

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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.