Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years old and willing and able to sign a written informed consent. - Eligible for Brain MRI - History of neurologic event or intervention OR future planned neurologic intervention

Exclusion Criteria

  • Contraindications to MRI of the brain - Patient declining participation in study

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Refractory Obsessive Compulsive Disorder fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical capsulotomy
  • Diagnostic Test: fMRI and DTI
    Neurologic imaging correlates
  • Behavioral: Behavioral questionnaires
    RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam
  • Behavioral: Disease-Specific Patient-Reported Outcomes
    Y-BOCS Survey, QUEST, PDQ39, PHQ2 Depression Screening, PHQ9 Depression Inventory, Beck's Depression Inventory, PROMIS Pain Intensity Short Form 3, McGill Pain Scale, Visual Analog pain scale, FTM (Tremor Scale)
  • Behavioral: Behavioral tests
    Behavioral tests may include one or more of the following procedures: Upper extremity testing, Perdue Peg Board testing, Hand tactile detection and discrimination test, Temperature and pain threshold testing, Lower extremity Testing, Myomotion Inertial Motion Testing.
Refractory Pain fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy
  • Diagnostic Test: fMRI and DTI
    Neurologic imaging correlates
  • Behavioral: Behavioral questionnaires
    RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam
  • Behavioral: Disease-Specific Patient-Reported Outcomes
    Y-BOCS Survey, QUEST, PDQ39, PHQ2 Depression Screening, PHQ9 Depression Inventory, Beck's Depression Inventory, PROMIS Pain Intensity Short Form 3, McGill Pain Scale, Visual Analog pain scale, FTM (Tremor Scale)
  • Behavioral: Behavioral tests
    Behavioral tests may include one or more of the following procedures: Upper extremity testing, Perdue Peg Board testing, Hand tactile detection and discrimination test, Temperature and pain threshold testing, Lower extremity Testing, Myomotion Inertial Motion Testing.
Refractory Tremor fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical thalamotomy
  • Diagnostic Test: fMRI and DTI
    Neurologic imaging correlates
  • Behavioral: Behavioral questionnaires
    RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam
  • Behavioral: Disease-Specific Patient-Reported Outcomes
    Y-BOCS Survey, QUEST, PDQ39, PHQ2 Depression Screening, PHQ9 Depression Inventory, Beck's Depression Inventory, PROMIS Pain Intensity Short Form 3, McGill Pain Scale, Visual Analog pain scale, FTM (Tremor Scale)
  • Behavioral: Behavioral tests
    Behavioral tests may include one or more of the following procedures: Upper extremity testing, Perdue Peg Board testing, Hand tactile detection and discrimination test, Temperature and pain threshold testing, Lower extremity Testing, Myomotion Inertial Motion Testing.
Refractory Depression fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy
  • Diagnostic Test: fMRI and DTI
    Neurologic imaging correlates
  • Behavioral: Behavioral questionnaires
    RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam
  • Behavioral: Disease-Specific Patient-Reported Outcomes
    Y-BOCS Survey, QUEST, PDQ39, PHQ2 Depression Screening, PHQ9 Depression Inventory, Beck's Depression Inventory, PROMIS Pain Intensity Short Form 3, McGill Pain Scale, Visual Analog pain scale, FTM (Tremor Scale)
  • Behavioral: Behavioral tests
    Behavioral tests may include one or more of the following procedures: Upper extremity testing, Perdue Peg Board testing, Hand tactile detection and discrimination test, Temperature and pain threshold testing, Lower extremity Testing, Myomotion Inertial Motion Testing.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232-5671
Contact:
Anthony J Cmelak, MD
615-322-2555
anthony.cmelak@vumc.org

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Anthony J Cmelak, MD
615-322-2555
anthony.cmelak@vumc.org

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.