Clinical Studies for Neurosurgery

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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 jaronson@bidmc.harvard.edu
 
Title: US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt System in the Treatment of Normal Pressure Hydrocephalus
Brief Title: NPH eShunt Study
Brief Summary: The eShunt® System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence.
For info regarding 2023P001179 please contact Christopher Ogilvy at 617-111-1111 or cogilvy@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 jaronson@bidmc.harvard.edu