Central Nervous SystemB-NETNCT03430427
Brain Networks and Mobility Function: B-NET
An observational study of Central Nervous System and White Matter Disease, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System, White Matter Disease
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2018to 12 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling adults reflecting the gender/race composition of Forsyth County in the target age-range will be identified. The 70 and up age-span was chosen because epidemiologic data shows accelerating functional decline and increased prevalence of white matter abnormalities across this age-range.
Who may be able to join
- Community-dwelling adults aged ≥70 years
- Willing to provide informed consent; ability to communicate with study personnel.
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Central Nervous System, White Matter Disease
- Keywords
- BNET, Brain Networks, Mobility Function, SMCCS
- Medical subject headings
- Leukoencephalopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6, 18, and 30 months
Secondary outcomes (2)
Change in Cardiovascular fitness
The fast-paced 400M walk protocol will be used.
Measured: baseline and 18 and 30 months
Change in Digit Symbol Substitution Test (DSST)
The WAIS-III Digit Symbol Substitution Test will be used.
Measured: baseline and 18 and 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start20 Jul 2018
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Stephen Kritchevsky, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430427
- Sponsor's protocol ID
- IRB00046460
- Other IDs
- 1R01AG052419-01A1
- Acronym
- B-NET
- Status last verified
- Aug 2023
- First submitted
- 26 Jan 2018
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Networks and Mobility Function: B-NET
- ClinicalTrials.gov ID
- NCT03430427
- Acronym / sponsor ID
- B-NET / IRB00046460
- Conditions
- Central Nervous System, White Matter Disease
- Keywords
- BNET, Brain Networks, Mobility Function, SMCCS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling adults reflecting the gender/race composition of Forsyth County in the target age-range will be identified. The 70 and up age-span was chosen because epidemiologic data shows accelerating functional decline and increased prevalence of white matter abnormalities across this age-range.
Key inclusion criteria (2 listed)
- Community-dwelling adults aged ≥70 years
- Willing to provide informed consent; ability to communicate with study personnel.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Change in Cardiovascular fitness
Time frame: baseline and 18 and 30 months
Change in Digit Symbol Substitution Test (DSST)
Time frame: baseline and 18 and 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- 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) StudyLink provided by the sponsor.
- Corrigendum: Examining the intersection of cognitive and physical function measures: Results from the brain networks and mobility (B-NET) studyLink provided by the sponsor.
- Examining the intersection of cognitive and physical function measures: Results from the brain networks and mobility (B-NET) studyLink provided by the sponsor.
- Associations of physical function and body mass index with functional brain networks in community-dwelling older adultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Kritchevsky, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System and White Matter Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Extended Short Physical Performance Battery (eSPPB) (time frame: baseline and 6, 18, and 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.