Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04688554 |
| Other study ID # |
200209 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 25, 2020 |
| Est. completion date |
August 25, 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Vanderbilt University Medical Center |
| Contact |
Anthony J Cmelak, MD |
| Phone |
615-322-2555 |
| Email |
anthony.cmelak[@]vumc.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A number of studies from the literature suggest important behavioral, psychosocial, or
radiologic changes occur following significant neurologic events or interventions such as
stroke, neurosurgery, medications, radiation, systemic therapy, or injury. The purpose of
this study is to describe these changes with advanced neurologic imaging and targeted
neurologic and neuropsychiatric assessments. This is a non-interventional observational study
of minimal risk to participants as there is no medical intervention. The results of this
study will be used to inform patients, scientists, and society in the development of future
treatments.
Description:
Functional magnetic resonance imaging (fMRI) and diffusion tensor tractography (DTI) have
rapidly expanded since its emergence two decades ago. fMRI is well established as the single
most powerful method for detecting changes in neural activity in vivo, albeit indirectly by
detection of changes in blood oxygenation level dependent (BOLD) signals that reflect
hemodynamic changes subsequent to neural activity. A conventional fMRI experiment involves
the comparison of two or more brain states followed by statistical tests to identify which
brain regions were involved in a particular task. The identification of patterns of highly
correlated low-frequency MRI signals in the resting brain provides a powerful approach to
delineate and describe neural circuits, and an unprecedented ability to assess the manner in
which distributed regions work together to achieve specific functions. Since the first
reports of temporal correlations in BOLD baseline signals, several distinct cortical
long-range networks have been identified and characterized in the resting state, including a
default mode network. Moreover, observations of altered resting state connectivity in several
disorders and as a function of behavior or cognitive skills suggest these correlations
reflect an important level of brain organization and may play a fundamental role in the
execution and maintenance of various brain functions. DTI is also an exceedingly important
imaging modality that has elucidated the neural connectivity inherent between various
cortical and subcortical structures. DTI is routinely used and has enhanced our understanding
of functional connections between various parts of the brain. Prior to interventions, DTI is
commonly obtained, so that interventionists can avoid critical circuitry. There is suggestion
that both fMRI and DTI imaging is influenced by organic or interventional variables, however
this is understudied. The neuroscientists and clinicians would greatly value information that
would expand our working knowledge of the basic neural substrates and functional neural
changes that occur in patients organically or after interventions. A non-invasive,
non-interventional, observational study is needed to show the changes that happen to patients
organically or in standard of care settings. A greater working understanding of the neural
connectivity and changes that happen in the brain is of great future benefit to patients,
science, and society as well as future therapeutic development such as post-stroke care,
rehabilitation, post-traumatic brain injury, or post-treatment care in the brain that has
previously been influenced by intervention or disease.
