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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT04577651
Eligibility Criteria:
Key Inclusion Criteria:
* Candidate for DBS implant in the treatment of Parkinson's disease
* Must be on stable anti-parkinsonian medications for 28 days prior to Informed Consent
* Persistent disabling Parkinson's disease symptoms such as dyskinesias, motor fluctuations, or disabling "off" periods despite optimal medical therapy
* Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system, etc.).
Key Exclusion Criteria:
* Any intracranial abnormality or medical condition that would contraindicate DBS surgery
* Have any significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders)
* Any current drug or alcohol abuse, as determined by the investigator
* Any history of recurrent or unprovoked seizures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04577651
Study Brief:
Protocol Section:
NCT04577651