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 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT02605161
Eligibility Criteria:
Inclusion Criteria:
* Disease burden is dominated by motor symptoms such as rigidity, bradykinesia, akinesia, and tremor;
* Medications have been optimized by a movement disorder neurologist;
* Adequate social support to assist with preoperative recovery and problems during subsequent programming;
* No major mood disorder and any mood disorders are medically optimized;
* No major cognitive impairment;
* No underlying medical conditions that would preclude surgery;
* Adequate response to levodopa, as assessed by UPDRS-3 on and off levodopa. All participants has at least a 30% improvement;
* eGRF\>30
Exclusion Criteria:
* Disease burden is not dominated by motor symptoms such as rigidity, bradykinesia, akinesia, and tremor;
* Medications have not bee optimized by a movement disorder neurologist;
* There is not adequate social support to assist with pre-operative recovery or problems during subsequent programming;
* Presence of major mood disorders or any mood disorders not medically optimized;
* Presence of major cognitive impairment;
* Presence of underlying medical conditions that would preclude surgery;
* Inadequate response to levodopa;
* eGFR\<30
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02605161
Study Brief:
Protocol Section:
NCT02605161