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Psychosocial, Behavioral, and Radiologic Changes Following Radiosurgery for Benign Neurologic Disease

Psychosocial, Behavioral, and Radiologic Changes Following Neurologic Events or Interventions: A Prospective, Non-Interventional, Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04688554
Enrollment
18
Registered
2020-12-30
Start date
2020-08-25
Completion date
2024-02-01
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Obsessive-Compulsive Disorder, Pain, Intractable

Keywords

Stereotactic Radiosurgery, Cingulotomy, Capsulotomy

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTfMRI and DTI

Neurologic imaging correlates

BEHAVIORALBehavioral questionnaires

RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam

BEHAVIORALDisease-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 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.

Sponsors

Varian Medical Systems
CollaboratorINDUSTRY
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Describe changes in Obsessive Compulsive Disorder disease burden after stereotactic radiosurgery.Every 3 months for 1 year or through study completionYale-Brown Obsessive Compulsive Scale questionnaire
Describe changes in Depression disease burden after stereotactic radiosurgery.Every 3 months for 1 year or through study completionBeck's Depression inventory
Describe changes in Pain disease burden after stereotactic radiosurgery.Every 3 months for 1 year or through study completionMcGill Pain Scale

Secondary

MeasureTime frameDescription
Describe changes in cognition after stereotactic radiosurgery.Every 3 months for 1 year or through study completionMontreal Cognitive Assessment
Describe changes in radiologic parameters after stereotactic radiosurgery.Every 6 months for 1 year or through study completionBrain MRI

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026