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Brain Networks and Mobility Function: B-NET (B-NET)

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ClinicalTrials.gov Identifier: NCT03430427
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
Rapidly accumulating evidence indicates that the central nervous system (CNS) plays a pivotal role in mobility function with age-associated CNS changes strongly contributing to declining mobility. Studies linking the brain to mobility have used anatomical measures like brain volume and white matter integrity, and suggest that damage to the connecting fibers of the brain (white matter) is related to mobility impairment. Unfortunately, age-related structural white matter damage appears irreversible and only indirectly indicates the functional connectivity between brain regions. It is believed that functional brain network analyses have the potential to identify individuals that may benefit from interventions prior to the development of irreversible white matter lesions. The current project will assess both physical and cognitive function and integrate these variables with measures of brain network connectivity.

Condition or disease
Central Nervous System White Matter Disease

Detailed Description:
Studies linking the brain to mobility have used anatomical measures like brain volume and white matter integrity, and suggest that damage to the connecting fibers of the brain (white matter) is related to mobility impairment. Unfortunately, age-related structural white matter damage appears irreversible and only indirectly indicates the functional connectivity between brain regions. The preliminary data show that directly assessed patterns of functional connectivity correlate with mobility function and can be changed by interventions that improve mobility function. It is not known how changes in CNS functional connectivity relate to changes in mobility, information critical for the design of interventions targeting CNS connectivity to improve mobility impairments. It is clear that structural connectivity underlies functional connectivity, and that structural brain lesions result in altered functional connections. B-NET will assess white matter (WM) disease burden and microstructural changes and relate these changes to functional brain network connectivity. We hypothesize that because sensory motor cortex community structure (SMC-CS) characterizes current brain organization, it will be associated with mobility function independently of anatomical damage markers. Such knowledge may permit earlier identification of persons at high risk for mobility decline and facilitate earlier and better targeted interventions.

Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Networks and Mobility Function: B-NET
Anticipated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort
Community-Dwelling Older Adults
The group will consist of 240 community-dwelling older adults with a range of mobility function based on the short physical performance battery (SPPB).



Primary Outcome Measures :
  1. Change in Extended Short Physical Performance Battery (eSPPB) [ Time Frame: baseline and 6, 18, and 30 months ]
    The expanded Short Physical Performance Battery (eSPPB) is a modified version of a widely used assessment of lower extremity physical function that consists of 3 standing balance tasks held for 10 seconds each (side-by-side, tandem and semi-tandem), two 4-m walk tests to assess usual gait speed, and 5 repeated chair stands. To minimize ceiling effects and maximize overall dispersion of test scores, the eSPPB increases the holding time of the semi- and full-tandem stands to 30 seconds and adds a single leg stand and a narrow walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). eSPPB scores are continuous and range from 0 to 4, with higher scores indicative of better performance.


Secondary Outcome Measures :
  1. Change in Cardiovascular fitness [ Time Frame: baseline and 18 and 30 months ]
    The fast-paced 400M walk protocol will be used.

  2. Change in Digit Symbol Substitution Test (DSST) [ Time Frame: baseline and 18 and 30 months ]
    The WAIS-III Digit Symbol Substitution Test will be used.


Other Outcome Measures:
  1. Change in Gait Speed [ Time Frame: baseline and 18 and 30 months ]
    This will be assessed over 4 meters 3 times at usual pace and 3 times at fast pace using an instrumented mat (GAITRite System), which provides data on average step and stride length, initial and terminal double support time, as well as the variability in these measures

  2. Change in lower extremity muscle strength [ Time Frame: baseline and 18 and 30 months ]
    Maximal isokinetic knee extension and flexion strength will be measured using an isokinetic dynamometer

  3. Change in postural sway [ Time Frame: baseline and 18 and 30 months ]
    Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform.


Biospecimen Retention:   Samples Without DNA
Serum and plasma will be retained for later analysis and for future research


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 85 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Community-dwelling adults reflecting the gender/race composition of Forsyth County in the target age-range will be identified. The 70-85 year age-span was chosen because epidemiologic data shows accelerating functional decline and increased prevalence of white matter abnormalities across this age-range.
Criteria

Inclusion Criteria:

  • Community-dwelling adults aged ≥70 to ≤85 years
  • Willing to provide informed consent; ability to communicate with study personnel.

Exclusion Criteria:

  • Serious or uncontrolled chronic disease such as:
  • Cancer (stage 3 or 4) or having had radiation or chemotherapy in the past year
  • Uncontrolled angina
  • Heart failure (stage 3-4)
  • Respiratory disease requiring the use of oxygen
  • Uncontrolled endocrine/metabolic disease (fasting glucose >250mg/dL)
  • Liver failure (AST > 40IU/L and/or ALT > 44 IU/L)
  • Renal failure requiring dialysis
  • Clinically diagnosed neurologic diseases: Parkinson's disease; Amyotrophic Lateral Sclerosis (ALS); Multiple Sclerosis, prior stroke with residual effects lasting longer than 24hrs
  • Diagnosis of schizophrenia, bipolar, or other psychotic disorder
  • Diagnosis of Alzheimer's disease or evidence of impaired cognitive function
  • Prior traumatic brain injury with residual deficits
  • Unwilling or unable to have an MRI brain scan (see MRI screening form).
  • Dependent on a walker or another person to ambulate.
  • Plans to relocate in the next 2- 3 years.
  • Single or double amputee
  • Musculoskeletal impairments severe enough to preclude functional testing
  • Participating in an exercise or cognitive enhancing intervention
  • Any other reason the PI or study physician feels the participant would not adhere to the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430427


Contacts
Contact: Stephen Kritchevsky, PhD 336-713-8987 skritche@wakehealth.edu
Contact: Kimberly Kennedy 336-713-8567 kkennedy@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Stephen Kritchevsky, Ph.D.    336-713-8987    skritche@wakehealth.edu   
Contact: Kimberly Kennedy    336-713-8567    kkennedy@wakehealth.edu   
Sub-Investigator: Paul Laurienti, MD         
Sub-Investigator: Laura Baker, PhD         
Sub-Investigator: Jonathan Burdette, MD         
Sub-Investigator: Michael Cartwright, MD         
Sub-Investigator: Jasmin Divers, PhD         
Sub-Investigator: Christina Hugenschmidt, PhD         
Sub-Investigator: Michael Miller, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Aging (NIA)
Investigators
Principal Investigator: Stephen Kritchevsky, PhD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03430427     History of Changes
Other Study ID Numbers: IRB00046460
1R01AG052419-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
BNET
Brain Networks
Mobility Function
SMCCS

Additional relevant MeSH terms:
Leukoencephalopathies
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases