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:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT03724734
Eligibility Criteria:
Inclusion Criteria:
* Study participants will be patients undergoing DBS of the subthalamic nucleus for the treatment of severe Parkinson's disease. Severe Parkinson's disease is defined as marked motor fluctuations (off periods and dyskinesias) despite optimal medical management. This is determined by the patient's clinical team.
* Able to give consent.
Exclusion Criteria:
* Cognitive impairment (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This includes anyone who, in the opinion of the clinician taking consent, is unlikely to retain sufficient mental capacity for the duration of their involvement in the study.
* Intracranial bleeding, confusion, cerebrospinal fluid leak or any other complication after the first stage of surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03724734
Study Brief:
Protocol Section:
NCT03724734