University of Maryland School of Medicine, USA
Charlene Aldrich has a Master’s degree in Nursing and has been involved in clinical trials in neuroscience for 25 years. She is the Clinical Research Manager in the Department of Neurosurgery and manages on an average 10 trials ranging from device trials to drug trials. Typical trials are multi-center national/international, prospective and are Federal or industry funded. She initiates and maintains all trials regulatory and clinical conduct for the respective principal investigators in the Department of Neurosurgery.
The UMD is participating in collaborative studies for treatment of ET and PD. MRI guided focused ultrasound (MRgFUS) is an attractive modality for non-invasive, thermal ablation of soft tissue and brain. This novel technology utilizes the combination of diagnostic imaging with high-intensity focused ultrasound. It concentrates energy from a source outside of the body on a small target-for PD and ET deep inside the brain. “Think sun–magnifying glass–leaf” PD and ET are caused by dysfunction of a circuit and system imbalance caused by functioning parallel circuits. Interruption of a specific parallel circuit using FUS rebalances the system, reducing symptoms (tremor/rigidity). Historical FUS lacked necessary precision; today precision have been overcome by coupling FUS to MRI simultaneous imaging of the target and the applied energy. The studies are designed as prospective, multi-center, single-arm feasibility studies to evaluate the safety and initial clinical effectiveness of ExAblate Transcranial unilateral thermal ablation of the globus pallidus of subjects suffering from medication-refractory advanced idiopathic PD.To Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
Subjects age 30 and older with confirmed medication-refractory, advanced idiopathic Parkinson’s disease or benign essential tremors are eligible for these studies.