Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-24 @ 2:30 PM
NCT ID:
NCT02963259
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT02963259
Study Brief:
Protocol Section:
NCT02963259