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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT04585451
Eligibility Criteria:
Inclusion Criteria:
* Male and female chronic pain patients
* Patients between the ages of 18-85 years
* Patients exhibiting the presence of symptoms in excess of 3 months duration
* Patients suffering from neuropathic (e.g., lower back pain), osteoarthritis, or muscular skeletal pain
* Patients with evidence of pathology related to the painful condition on which diagnosis was made (e.g., results of imaging or diagnostic pain code)
Patients with NRS pain scores across the full range (1-10) at the time of testing Inclusion Criteria, Normal (no-pain) Group
o Subjects will be included with no history of pain with a duration of greater than 3 months, and no report of pain at the time of testing (or within 3 months of testing)
Exclusion Criteria:
* Patients with medically diagnosed psychotic illness
* Patients with medically diagnosed drug or alcohol dependence in the past 12 months
* Patients with a medical history of head injury with loss of consciousness and amnesia (within the last 2 years)
* Patients with skull abnormalities that preclude the proper placement of the electrodes for the EEG data acquisition
* Patients who have a spinal cord stimulator, or other implantable devices
* Patients for whom the source of pain at the time of the evaluation is associated with: neurological disorders (multiple sclerosis, Parkinson, dementia), diabetes, migraines, or those with reflex / sympathetic dystrophy disorder/complex regional pain syndrome, fibromyalgia, or visceral pain
Note: This does not exclude patients who suffer from these disorders if the current source of pain is not due to the disorder. For example, patients with diabetes are NOT excluded, but patients whose pain at the time of the evaluation is a result of diabetic neuropathy are excluded. Similarly, patients with a history of migraines but for whom a migraine is not the current source of pain at the time of the evaluation are NOT excluded.
* Patients with cancer
* Patients on workers compensation or disability
* Patient on anticonvulsant medication
* Patients who have a history of seizures
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04585451
Study Brief:
Protocol Section:
NCT04585451