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 @ 12:51 PM
Ignite Modification Date:
2025-12-24 @ 12:51 PM
NCT ID:
NCT06701461
Eligibility Criteria:
Study subjects
Inclusion Criteria:
* Kellgren-Lawrence Grade \>= 3
Exclusion Criteria:
* Inflammatory arthropathy (e.g., rheumatoid arthritis), BMI \>=35
Control subjects:
Exclusion Criteria:
* Complaints of lower extremity joint pain
* Known diagnosis of knee osteoarthpathy
* Prior history of knee surgery, knee injections, or injury to knee joints (e.g., meniscus tears, ligamentous injuries), BMI \>=35
Both groups, exclusion:
* Subjects with chronic heart problems, including, but not limited to, chronic hypertension, heart palpitations, a weak or irregular heartbeat, or a previous heart attack,
* Subjects taking the following drugs within 12 hours of the experiment or during the experiment: caffeine, alcohol, psychoactive drugs, nicotine or marijuana, other recreational drugs, and medicine of any kind that is not normally taken daily. Such medications include;
* NSAIDs
* Acetaminophen
* Steroidal anti-inflammatory agents
* Bronchodilators
* Appetite suppressants
* Lipase inhibitors
* Women who are currently pregnant
* Subjects with Raynaud's syndrome
* Subjects with any of the following conditions: active skin lesions where EDA sensors are, vertigo or dizziness, and anyone with postural orthostatic tachycardia syndrome (POTS), peripheral neuropathy, seizure disorders, methicillin-resistant staphylococcus aureus (MRSA), impaired circulation, medical implants, open skin lesions, chronic eczema on hands where EDA and electrical stimulator's electrodes are attached, diabetes, and epilepsy.
* Participants who have a skin sensitivity to metals, have a pacemaker or defibrillator, or have recent head trauma within the past two weeks (even without loss of consciousness)
* Participants who cannot feel physical pain or have a history of self-harm
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT06701461
Study Brief:
Protocol Section:
NCT06701461