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:
NCT02610634
Eligibility Criteria:
Inclusion Criteria:
Common to all groups
* Aged ≥50 years
* Able to walk unaided
* Adequate hearing (as evaluated by the whisper test; stand 2m behind participant and whisper a 2 syllable word, participant repeats word) and vision capabilities (as measured using a Snellen chart - 6/18-6/12).
* Stable medication for the past 1 month and anticipated over a period of 6 months
Group Specific Criteria
Participants with PD:
* Diagnosis of idiopathic PD, as defined by the UK Brain Bank criteria
* Hoehn and Yahr stage I-III
* Stable medication for past 1 month and anticipated over next 6 months or stable Deep Brain Stimulation for at least one month and expected following 6 months
* Score ≥21/30 on Montreal cognitive assessment (MoCA) which is used to classify non-demented PD (PD dementia is \<21/30)
* Free from any neurological disorders that may have caused cognitive impairment
* No restriction was made for medication usage and participants on stable doses of medication or treatment were permitted.
Exclusion Criteria:
Common to all groups
* Psychiatric co-morbidity (e.g., major depressive disorder as determined by geriatric depression scale (GDS-15); \>10/15)
* Clinical diagnosis of dementia or other severe cognitive impairment (PD = MoCA \<21/30, Controls = MoCA \<26/30)
* History of stroke, traumatic brain injury or other neurological disorders (other than PD, for that group)
* Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
* Unstable medical condition including cardio-vascular instability in the past 6 months
* Unable to comply with the testing protocol or currently participating in another interfering research project
* Interfering therapy
Vision specific Criteria
* Any pupillary diameter disorder; such as significantly non-round pupils, Adies pupil (tonic or dilated pupil), Argyll-Robertson pupil (absence of light reaction), unilateral small pupil
* Neuromotility disorders, such as Nystagmus or other ocular oscillations
* Significant left eye disorders (i.e. squint, twitching, Ptosis \[drooping eyelids\])
* Known significant visual field deficits; such as hemianopia
* Optic nerve disease
* Optic disc elevation
* Optic disc swelling; such as Papilledema or Papillitis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02610634
Study Brief:
Protocol Section:
NCT02610634