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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT00350402
Eligibility Criteria:
Inclusion Criteria:
* A clinical diagnosis of idiopathic Parkinson disease
* Hoeh-Yahr Stage 1-3 when off medication
* Stable and optimal medical regimen for at least 3 months
* No previous surgical interventions for Parkinson's disease (i.e., deep brain stimulation, pallidotomy, stem cell implantation)
* Participants will include men and women between the ages of 45 and 80 years
Exclusion Criteria:
* Evidence of dementia based on neurocognitive testing
* Current or past history of major psychiatric disturbance (e.g., schizophrenia, bipolar disorder, substance abuse). Participants who are taking anti-depressants will not be excluded as long as they are not currently depressed (Beck Depression, SCID)
* Other neurologic disturbance (e.g., tumor, stroke, traumatic brain injury, epilepsy) or severe chronic medical illness (e.g., HIV, metastatic cancer)
* Presence of oro-facial dyskinesias
* Previous surgeries to the larynx that result in poor vocal fold closure and/or positive history of head and neck cancer
* History of smoking in the past 5 years
* Untreated hypertension
* Failing a baseline test of pulmonary function during baseline respiratory evaluation
* Known respiratory complications such as chronic obstructive pulmonary disease (POCD), asthma
* Previous surgical interventions for Parkinson's disease (i.e., deep brain stimulation, pallidotomy, stem cell implantation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT00350402
Study Brief:
Protocol Section:
NCT00350402