Status:
COMPLETED
Exploration of Blood Flow Regulation to Bone in Humans
Lead Sponsor:
Spaulding Rehabilitation Hospital
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Bone Blood Flow Regulation
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Without blood flow, bone cannot maintain its integrity. Bone blood flow responds to various local and systemic factors, however, bone perfusion in humans remains relatively unstudied. The investigator...
Detailed Description
All tissues of the human body require adequate perfusion to provide oxygen and nutrients to meet metabolic demands. It has long been known that the arterial system in bone is of overwhelming importanc...
Eligibility Criteria
Inclusion
- healthy males and females
- individuals with spinal cord injuries, between 3 and 24 months post injury, with complete injuries according to the American Spinal Injury Association Impairment Scale A and B, with injuries at T6 and below
Exclusion
- clinical signs or symptoms of heart disease
- hypertension
- coronary disease
- diabetes
- other neurological disease
- cancer
- recent weight change \>15 pounds
- abnormal resting ECG
- pregnant and/or breastfeeding women
- underweight and obese individuals (body mass index between 18.5 and 29.9)
- use of amphetamines (Ritalin, Adderall, Concerta) in the past 48 hours
- tibial fracture or tibial stress fracture in the past year
- those with SCI will have no extreme spasticity to avoid spontaneous contractions
- use of baclofen for those with SCI
Key Trial Info
Start Date :
May 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04083794
Start Date
May 31 2018
End Date
April 13 2023
Last Update
June 17 2024
Active Locations (1)
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1
Spaulding Rehabilitation Cambridge/ Cardiovascular Laboratory
Cambridge, Massachusetts, United States, 02138