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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT03422757
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of idiopathic PD;
* DBS implant since at least 3 years and in need of battery replacement, defined by battery level \<25%;
* Patients must be able to sign the informed consent document to participate in the clinical trial;
* Patients with a suboptimal response to DBS treatment.
Exclusion Criteria:
* Patients with severe cognitive decline (MMSE \<25);
* Patients with major psychiatric issues;
* Patients with any medical condition potentially interfering with DBS battery replacement surgery;
* Patients that cannot tolerate an interruption of DBS stimulation;
* Patients taking only one levodopa dose per day;
* Patients with no LFPs recorded from any contacts pair, during intraoperatory IPG replacement procedure;
* Pregnant or breastfeeding women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03422757
Study Brief:
Protocol Section:
NCT03422757