MedTrace Logo

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

NCT04688554 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2024-12-06

No results posted yet for this study

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.

Conditions

  • Obsessive-Compulsive Disorder
  • Pain, Intractable
  • Depression

Interventions

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.

Sponsors & Collaborators

  • Varian Medical Systems

    collaborator INDUSTRY

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Anthony J Cmelak, MD · Vanderbilt University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2024-02-01
Completion
2024-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04688554 on ClinicalTrials.gov