Objective: We examine DBS and RNS trials from 1997-2022, chart their characteristics, and examine rates and predictors of results reporting.

Background: Prompt dissemination of clinical trial results is essential for ensuring the safety and efficacy of deep brain stimulation (DBS) and responsive neurostimulation (RNS). However, the frequency and completeness of results publication are unknown. Moreover, the patient populations, targeted anatomical locations, and stimulation parameters should be clearly reported for both reproducibility and to identify lacunae in trial design

Method: Trials were identified using ClinicalTrials.gov. Associated publications were identified using ClinicalTrials.gov and PubMed.gov. Pearson’s Chi-squared tests were used to assess differences in trial characteristics between published and unpublished trials.

Results: Across 449 trials, representing a cumulative cohort of 42,769 patient interventions, there were 37 therapeutic indications and 44 stimulation targets. The most common indication and target were Parkinson’s Disease (40.55%) and subthalamic nucleus (35.88%), respectively. Only 0.89% of trials were in pediatric patients (11.58% were mixed pediatric and adult). Explored targets represented 75% of potential basal ganglia targets, but only 29% of potential thalamic targets. Allowing a 1-year grace period after trial completion, 34/169 (20.12%) had results reported on ClinicalTrials.gov and 107/169 (63.31%) were published. ~80% of published trials included details about stimulation parameters used. Published and unpublished trials did not significantly differ by trial characteristics.

Conclusion: We highlight key knowledge and performance gaps in DBS and RNS trial research. Over one-third of trials remain unpublished >1 year after completion; pediatric trials are scarce; most of the thalamus remains unexplored; about one-in-five trials fail to report stimulation parameters; and movement disorders comprise the most studied indications.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/publication-rates-and-characteristics-of-clinical-trials-in-deep-brain-and-responsive-neurostimulation/