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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT01758692
Eligibility Criteria:
Inclusion Criteria:
For All Groups:
* Age 18-65 years (18-89 years for Non-Invasive Only SCI Subjects)
* Stable health for \> 6 months
* Non-smoker
o Subjects with SCI:
* Level of injury - C1-S4
* Duration of injury - ≥ 1 year
* AIS classification - A, B, C
Exclusion Criteria:
For Main Study SCI Group:
* Tachycardia (resting HR ≥ 100 bpm)
* Bradycardia (resting HR ≤ 40 bpm)
* Hypertension
* KNOWN:
Coronary artery disease, Chronic heart failure, Cardiac arrhythmias, Diabetes mellitus, Thyroid disease, Renal insufficiency, Hepatic disease, Autonomic neuropathy, Ulcerative colitis, Benign prostatic hyperplasia, Hiatal hernia, Glaucoma, Parkinson's disease, Stroke, other neuromuscular diseases, Known sulfite allergy or hypersensitivity, Asthma, Active illness or infection, For Non-invasives Only SCI Group
* Diabetes mellitus
* Autonomic neuropathy
* Parkinson's disease
* Active illness or infection
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT01758692
Study Brief:
Protocol Section:
NCT01758692