Status:
COMPLETED
Blood Pressure, Cerebral Blood Flow and Cognition in Spinal Cord Injury
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Collaborating Sponsors:
Kessler Foundation
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Following spinal cord injury autonomic regulation of the cardiovascular system is impaired, which results in a variety of measurable abnormalities in blood pressure. Evidence of causality has been doc...
Detailed Description
Acute Study:The purpose of this research study is to measure a spinal cord injured individual's blood pressure and blood flow to the brain at rest and during thinking tasks before and after a single d...
Eligibility Criteria
Inclusion
- Spinal Cord Injured
- Between the ages of 18-65 years old.
- Level of injury is between C1-T12
- Primarily wheelchair dependent for ambulation
- Have a spinal cord injury that is ASIA Impairment Scale (AIS) grade of A, B or C
- Injury occurred more than 1 year ago
- Low blood pressure (Systolic BP less than 110 mmHg for males, Systolic BP less than 100 mmHg for females)
- Primary language is English
- I am right handed
Exclusion
- Currently have an illness or infection
- Severe history of AD (more than 3 symptomatic events per week, evidence of blood pressure elevations above 140/90 mmHg,significant adverse subjective symptoms reporting)
- Hypertension or diabetes
- History of Traumatic Brain Injury (TBI)
- Neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.)
- History of epilepsy or other seizure disorder
- Diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder
- Within the past 6 months, abused illicit drugs
- Pre-screen mini mental status exam score of less than 24, as rated by the researcher
- Vision is impaired- more than 20/60 in worst eye (with prescription eyewear)
- Coronary heart and/or artery disease
- Major surgery in the last 30 days
- Pregnant
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02307565
Start Date
March 1 2014
End Date
December 1 2019
Last Update
February 21 2025
Active Locations (2)
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1
Kessler Foundation Research Center
West Orange, New Jersey, United States, 07052
2
James J Peters VAMC
The Bronx, New York, United States, 10468