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 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
NCT ID:
NCT04665492
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for patients with SCI and NO chronic pain are as follows:
* Age between 18-80
* Subacute spinal cord injury (within 6 months post injury)
* Level C3-T12
* ASIA A, B, C or D
* Normal or corrected to normal vision
* No allodynia or hyperalgesia
Inclusion criteria for patients with SCI and CNP are as follows:
* Age between 18-80
* Subacute spinal cord injury (within 6 months of injury)
* Level C3-T12
* ASIA A, B, C or D
* Normal or corrected to normal vision
* Presence of allodynia or hyperalgesia
* Diagnosed CNP related to SCI equal or larger than 4 on visual numerical scale (VNS)
Inclusion criteria for able-bodied participants:
* Age 18-80
* No self-reported neurological conditions
* No chronic or acute pain equal or larger than 3 on VNS
* Normal or corrected to normal vision
* English speaker
Exclusion Criteria:
Exclusion criteria for patients with and without CNP:
* Inability to understand the task
* Inability to sit for at least 2 hours (duration of EEG assessment)
* Invasive 24/7 ventilation
* Previously confirmed brain injury, (peripheral nerve injury and brachial plexus injury)
* Other self-reported neurological condition that would affect EEG recording
* Presence/history of any other chronic or acute pain (larger or equal to 3 on the VNS)
* Pressure sores or any other condition that might prevent sitting for 2 hours
* Halos or neck support that prevent EEG recording
* Infections of the skin or communicable diseases (e.g. hospital bugs)
* Concurrent acute medical problems (e.g. infections)
* Infection control issues i.e. the need for patient isolation
* Do not understand English
Able bodied people and people who had spinal cord injury and are still in subacute phase (6 monthExclusion Criteria for able-bodied participants:
* Unable to give informed consent
* Presence of chronic or acute pain equal to or larger than 3 on VNS
* Any self-reported neurological conditions
* Non-English Speaker s post injury)
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04665492
Study Brief:
Protocol Section:
NCT04665492