The Current State of Clinical Trials Studying Hydrocephalus: An Analysis of ClinicalTrials.gov

Abstract

Introduction Hydrocephalus is a significant public health concern estimated to affect 380,000 new individuals annually. In addition, it exhibits an increasingly high financial burden for the healthcare industry. Clinical trials are the gold standard for evaluating preventative and therapeutic strategies to bring potential treatments to the forefront of clinical practice. Methods A study of the ClinicalTrials.gov was conducted in April 2019 to examine all current and previously reported clinical trials studying hydrocephalus. Studies were reviewed to extrapolate information to characterize the current state of research being conducted for hydrocephalus. Results In total, 80 clinical trials met inclusion criteria and were analyzed: 48.8% were observation and 51.2% were interventional. Of those, 55% have been completed while 30.0% are still recruiting, and 15.0% are not yet recruiting. The United States has the most clinical trials (42.0%) and a plurality of trials has a sample size of 0-50 participants. The majority of studies included only adults (53.8%). Of those studies, 54.0% were cohort and the majority were prospective (74.0%). Of the different types of hydrocephalus, normal pressure hydrocephalus and pediatric hydrocephalus have generated the most interest for research comprising a majority of the clinical trial registry. While 44 of the trials are complete, only 20 have published results in peer-reviewed literature highlighting the need for improvement in publishing study results even if the results of the trials are null. Conclusion Most clinical trials to date have pertained to the treatment of normal pressure hydrocephalus and pediatric hydrocephalus. While great advancements have been made for the treatment of hydrocephalus, there remains much room for improvements in therapeutic interventional modalities as well as ensuring the reporting of all undertaken clinical trials.

Keywords: hydrocephalus; normal pressure hydrocephalus; pediatric hydrocephalus; post-hemorrhagic hydrocephalus; review of clinical trials.

Figure 1. Number of Clinical Trials Beginning Stratified by Year