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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT04876404
Eligibility Criteria:
Parkinson's Disease Individuals
Inclusion Criteria:
i. Recently diagnosed with early stage Parkinson's Disease (within 5 years of diagnosis) ii. Between the ages of 50 to 85 iii. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Healthy Control Individuals
Inclusion Criteria:
i. Healthy male between the ages of 50 and 85 ii. Healthy female between the ages of 50 and 85 iii. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Exclusion Criteria (All Individuals):
i. Current or past major psychiatric disorders (e.g. depression, anxiety disorders) or other major neurological disease ii. Current or past substance use problems iii. Serious head injury with loss of consciousness for ≥ 5 minutes iv. Fear of enclosed, confined spaces v. Pregnant or breastfeeding vi. Presence of active, recent, or repeated cancer vii. Unstable/undiagnosed medical conditions viii. Certain medications or conditions may impact the ability to participate and these will be discussed on a case by case basis with the study team.
ix. Weight of more 158 kg x. Inability to remain still during the scans. xi. People for whom MRI is contra-indicated:
* People with a non-MRI safe intrauterine device (IUD);
* Machinist or Metalworkers;
* Cardiac pacemaker, wires or defibrillator;
* Past injury where a piece of metal lodged in your eye or orbit;
* Ferromagnetic aneurysm clip;
* Artificial heart valve;
* Brain aneurysm clip;
* Electrical stimulator for nerves or bones or brains;
* Ear or eye implant;
* Implanted drug infusion pump;
* Coil, catheter, or filter in any blood vessel;
* Orthopaedic hardware (artificial joint, plate, screws);
* Other metallic prostheses;
* Shrapnel, bullets, or other metal fragments;
* Surgery (brain or otherwise), tattoos or injection into a join in the last 6 weeks
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT04876404
Study Brief:
Protocol Section:
NCT04876404