Clinical Studies for Neurosurgery

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Title: Evaluation of Long-term Neuropsychologic and Cognitive Outcomes in Patients with Unruptured Intracranial Aneurysms
Brief Title: Neuropsychologic Outcomes for UIAs
Brief Summary: The aim of this study is to investigate neurocognitive effects of UIA treatment in patients receiving elective treatment at BIDMCs Neurosurgical Department for UIAs. Therefore, a longitudinal study design has been chosen, in which 200 patients across two sites will be evaluated neuropsychologically on 3 separate occasions: on first clinic visit, 3 months after diagnosis or treatment, and 1 year after diagnosis or treatment. This information will be gathered and evaluated for outcomes of neurocognitive functioning after treatment.
For info regarding 2025P001062 please contact Mark Rotondo, MS at 617-632-7025 or mrotondo@bidmc.harvard.edu
 
Title: Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt System in the Treatment of Normal Pressure Hydrocephalus (STRIDE)
Brief Title: STRIDE E-Shunt Study
Brief Summary: Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
For info regarding 2025P000157 please contact Christopher Ogilvy at 617-111-1111 or cogilvy@bidmc.harvard.edu
 
Title: Treatment Resistant Depression Subcallosal Cingulate Network DBS
Brief Title: TRANSCEND Study
Brief Summary: The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.
For info regarding 2024P000577 please contact Joshua Aronson at 617-632-7023 or jaronson@bidmc.harvard.edu
 
Title: A First-in-human (FIH) Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
Brief Title: NTE001
Brief Summary: This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA).
For info regarding 2023P000349 please contact Joshua Aronson at 617-632-7023 or jaronson@bidmc.harvard.edu