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

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

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-25

Study Completion Date

2024-02-01

Brief Summary

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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

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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.

Conditions

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Obsessive-Compulsive Disorder Pain, Intractable Depression

Keywords

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Stereotactic Radiosurgery Cingulotomy Capsulotomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Anthony Cmelak

Professor, Department of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony J Cmelak, MD

Role: STUDY_CHAIR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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200209

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Refractory Obsessive Compulsive Disorder

fMRI and DTI

Behavioral questionnaires

Disease-Specific Patient-Reported Outcomes

Behavioral tests

Refractory Pain

fMRI and DTI

Behavioral questionnaires

Disease-Specific Patient-Reported Outcomes

Behavioral tests

Refractory Tremor

fMRI and DTI

Behavioral questionnaires

Disease-Specific Patient-Reported Outcomes

Behavioral tests

Refractory Depression

fMRI and DTI

Behavioral questionnaires

Disease-Specific Patient-Reported Outcomes

Behavioral tests

Interventions

fMRI and DTI

Behavioral questionnaires

Disease-Specific Patient-Reported Outcomes

Behavioral tests

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Varian Medical Systems

Vanderbilt University Medical Center

Responsible Party

Anthony Cmelak

Principal Investigators

Anthony J Cmelak, MD

Locations

Vanderbilt University Medical Center

Countries

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

Other Identifiers

200209