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 @ 7:03 PM
Ignite Modification Date:
2025-12-24 @ 7:03 PM
NCT ID:
NCT06688357
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of idiopathic Parkinson disease by movement disorder neurologist using UK Brain Bank criteria
* Early-mid stage of disease severity
* Willingness to undergo baseline and post-intervention 'off' their normal dopamine medications
* Between 62 and 89 years of age
* Able to provide informed consent and perform cognitive and mood measures on a computer
* Willingness to be randomized to Sham or Real intervention
* Can devote 2 weeks to the intervention, and additional time for pre and post testing
* 8th grade education and ability to read on 8th grade level based on scores on the Wechsler Test of Adult Reading (WTAR) or the Wide Range Achievement Test-IV (WRAT-IV); ability to see 14 pt. text
* On stable doses of major medications for at least two months
Exclusion Criteria:
* History of brain abnormalities/ neurological disorders affecting cognition other than PD; No history of brain surgery
* Evidence of potential dementia based on cognitive screening (e.g., scores \< 5th %ile on the Montreal Cognitive Assessement (MoCA) or the Dementia Rating Scale-2 (DRS-2) based on appropriate age, education and sex norms.
* Use of psychotics, sedatives or other medications with anticholinergic properties;
* Unstable or uncontrolled medical conditions (e.g.,HIV, severe kidney disease)
* Diagnosis of active cancer
* Use of photosensitive medications within 15 days of intervention
* Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental cognitive tasks or neuropsychological assessment
* Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months. The investigators are not excluding individuals who are taking antidepressants or anti-anxiety medications, however, use of antidepressants and anxiolytics will be recorded and data will be analyzed in post-hoc analyses
* Previous participation in a cognitive training study within the last six months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
62 Years
Maximum Age:
89 Years
Study:
NCT06688357
Study Brief:
Protocol Section:
NCT06688357