Brain Networks and Mobility Function: B-NET

NCT ID: NCT03430427

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-20

Study Completion Date

2023-07-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Central Nervous System White Matter Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Kritchevsky, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Related Links

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https://pubmed.ncbi.nlm.nih.gov/33477358/

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

https://pubmed.ncbi.nlm.nih.gov/36936506/

Corrigendum: Examining the intersection of cognitive and physical function measures: Results from the brain networks and mobility (B-NET) study

https://pubmed.ncbi.nlm.nih.gov/36819728/

Examining the intersection of cognitive and physical function measures: Results from the brain networks and mobility (B-NET) study

https://pubmed.ncbi.nlm.nih.gov/37054493/

Associations of physical function and body mass index with functional brain networks in community-dwelling older adults

Other Identifiers

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1R01AG052419-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00046460

Identifier Type: -

Identifier Source: org_study_id

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