N/A
N=90
Exploration of Blood Flow Regulation to Bone in Humans
Bone Blood Flow Regulation
Bottom Line
View on ClinicalTrials.gov: NCT04083794 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Tibial Blood Perfusion — 0.54; -1.47; 0.43; 2.08 μM (concentration)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laboratory based assessments (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tibial Blood Perfusion |
0.54; -1.47; 0.43; 2.08; 3.42; 1.55 | — |
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 investigators will study key mechanisms that regulate bone perfusion in able-bodied and contrast responses to those with spinal cord injury (SCI). SCI is a model of chronic reduced loading with loss of sympathetic regulation. In tibial cortical bone, the investigators will: 1) determine the impact of compressive loading with and without muscle contractions; 2) determine the impact of vascular sympathetic activity and systemic perfusion pressure; 3) compare the response between able-bodied and those with SCI. Acute metabolic needs of bone due to loading increase flow substantially. In addition, the bone vasculature is innervated by a rich network of sympathetic nerves that serve a functional purpose in the control of blood flow. A critical limitation to the study of bone blood flow in humans has been the lack of non-invasive assessments. Previously, the investigators developed a near infrared spectroscopy (NIRS) device to non-invasively assess blood content in bone and assessed tibial perfusion in response to exercise. Here, the investigators will test the hypothesis that bone blood flow increases proportional to loading conditions in both able-bodied individuals and those with SCI. The investigators will also test the hypothesis that there are decreases in blood bone flow that are proportional to increases in leg vascular sympathetic outflow in the able-bodied, but that changes in bone blood flow are proportional to changes in blood pressure in those with SCI. The proposed research will be some of the first to determine the control of bone flow in humans.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04083794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.