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 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT02983266
Eligibility Criteria:
Group 1 \& 2:
Inclusion Criteria:
1. Age 18-65
2. Willingness to participate in the study
Exclusion Criteria:
1. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
2. Use of a hearing aid in the left ear
3. Use of an implanted insulin or morphine (pain) pump
4. Self-reported history of syncope from known or unknown origins
5. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)
Group 3:
Inclusion Criteria:
1. Age 18-65
2. Overweight, with a BMI ≥ 27
3. Presence of chronic inflammation, with C-reactive protein values \> 3 mg/l
4. Willingness to participate in the study
Exclusion Criteria:
1. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
2. Use of a hearing aid in the left ear
3. Use of an implanted insulin or morphine (pain) pump
4. Self-reported history of syncope from known or unknown origins
5. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)
6. Use of statin drugs
Group 4:
Inclusion Criteria:
1. Age 18-65
2. ≥ 1-year post-injury
3. Bladder management by clean intermittent catheterization
4. Spinal cord injury resulting in Paraplegia level T1 to T6 and motor-complete (AIS A or B) impairment. Injury level and impairment will be confirmed by an ASIA exam conducted less than 2 years before study entry. If longer than 2 years, we will have a certified rater repeat the exam.
5. Participant report of symptoms related to autonomic dysreflexia during episodes of full bladder or voiding, including elevated BP, mild headache, paresthesia, chills, nasal congestion, flushing of the skin, or diaphoresis.
6. Willingness to participate in the study.
Exclusion Criteria:
1. Currently hospitalized
2. American Spinal Injury Association (AIS) C-E
3. Currently using an insulin, morphine (pain), or intrathecal pump
4. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
5. Use of a hearing aid in the left ear
6. Self-reported history of syncope from known or unknown origins
7. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02983266
Study Brief:
Protocol Section:
NCT02983266