University Medical Center started a clinical trial of Psychosocial, Behavioral, and Radiologic Changes Following Radiosurgery for Benign Neurologic Disease
The Vanderbilt University Medical Center is commencing recruitment for the clinical trial of the Psychosocial, Behavioral, and Radiologic Changes Following Radiosurgery for Benign Neurologic Disease.
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.
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.
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.
It is planned to include 50 participants.
Actual study start date is August 25, 2020. The researchers expect to complete the study by August 25, 2025.
One primary outcome measure is describe changes in Depression disease burden after stereotactic radiosurgery.
Among study population are VUMC adult patients with neurologic disease or patients with neurologic interventions such as neurosurgical procedures or radiation therapy. Men and women of any ethnicity, race or socioeconomic status who meet inclusion criteria will be offered enrollment into the study. Patient will be greater than 18 years of age and meet inclusion and exclusion criteria. Patients eligible for this study will include patients with neurologic events, including but not limited to stroke, depression, infections, psychiatric disease. Intervention is not part of this study, however, patients receiving neurologic interventions, such as neurosurgical procedures or radiation therapy, would be eligible.
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04688554) Nashville, United States.
