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 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT06000592
Eligibility Criteria:
Inclusion Criteria:
* Newly injured patients with traumatic SCI
* Admitted to Acute Inpatient Rehabilitation at Mount Sinai
* Within one year of SCI
* Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females)
* Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position)
* Daily fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg
* At least 14 years old
Exclusion Criteria:
* Implanted brain/spine/nerve stimulators
* Cochlear implants
* Cardiac pacemaker/defibrillator, or intracardiac lines
* Open skin lesions on or near the electrode placement sites (neck, upper back)
* Significant coronary artery or cardiac conduction disease
* Recent history of myocardial infarction
* Insufficient mental capacity to understand and independently provide consent
* Pregnancy
* Cancer
* Deemed unsuitable by study physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
100 Years
Study:
NCT06000592
Study Brief:
Protocol Section:
NCT06000592