Brain Networks and Mobility Function: B-NET

Central Nervous System Clinical Trial

— B-NET  

Official title:

Brain Networks and Mobility Function: B-NET

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430427
• Other study ID #: IRB00046460
• Secondary ID: 1R01AG052419-01A
• Status: Completed
• Start date: July 20, 2018
• Est. completion date: July 12, 2023

Study information

• Verified date: August 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Community-dwelling adults aged =70 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

Related Conditions & MeSH terms

• Central Nervous System
• Leukoencephalopathies
• White Matter Disease

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Gait Speed	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	baseline and 18 and 30 months
Other	Change in lower extremity muscle strength	Maximal isokinetic knee extension and flexion strength will be measured using an isokinetic dynamometer	baseline and 18 and 30 months
Other	Change in postural sway	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.	baseline and 18 and 30 months
Primary	Change in Extended Short Physical Performance Battery (eSPPB)	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.	baseline and 6, 18, and 30 months
Secondary	Change in Cardiovascular fitness	The fast-paced 400M walk protocol will be used.	baseline and 18 and 30 months
Secondary	Change in Digit Symbol Substitution Test (DSST)	The WAIS-III Digit Symbol Substitution Test will be used.	baseline and 18 and 30 months

External Links

•   Associations of physical function and body mass index with functional brain networks in community-dwelling older adults
•   Corrigendum: Examining the intersection of cognitive and physical function measures: Results from the brain networks and mobility (B-NET) study
•   Effects of a Motor Imagery Task on Functional Brain Network Community Structure in Older Adults: Data from the Brain Networks and Mobility Function (B-NET) Study
•   Examining the intersection of cognitive and physical function measures: Results from the brain networks and mobility (B-NET) study