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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT03267550
Eligibility Criteria:
Inclusion Criteria:
* Primary PD patients volunteered to receive DBS surgery with SceneRay wireless and remote DBS system,
* Age 18-75 years,
* Achieved optimal control of clinical symptoms after coventional programming for 3-12 months,
* Significant difference in motor function when DBS is switched on/off,
* Good compliance and easy to follow-up,
Exclusion Criteria:
* No significant improvement or clinical efficacy in symptoms after surgery,
* Severe cognitive impairment due to dementia (Mini-Mental State Examination score: illiteracy \<17, elementary school \<20, junior high school or above \<24) or inability to accurately record in a diary,
* Active psychosis or a history of psychosis,
* Serious heart, liver, or kidney diseases,
* Severe hypertension or orthostatic hypotension, severe diabetes, or diabetes accompanied by brain and cardiovascular diseases,
* Malignant cancer, brain injuries, epilepsy, or other unstable medical conditions,
* Severe alcohol dependence or drug abuse,
* Any situation that may jeopardize the patient's safety or lead to a failure to participate in the study (medical, psychological, social, or georational factors) at present or in the future,
* Participating in other clinical trials,
* Other factors that researchers think may not be suitable for research.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03267550
Study Brief:
Protocol Section:
NCT03267550