Effects of Diazepam on RNS Detections

Epilepsies, Partial Clinical Trial

Official title: Exploratory Open-Label Study of Effects on Responsive Neurostimulator Activity After Intranasal Administration of Single Dose of Valtoco® to People With Epilepsy

Status Completed

Clinical Trial Summary

To assess the magnitude and duration of reduction in RNS recorded Detections and Long Episodes following intranasal administration of Valtoco®. All participants will have been implanted and treated with an RNS system for clinical purposes and regularly upload Detection and Long Episode data on a regular basis as part of regular clinical treatment. Participants will come to the clinic and be administered a single dose of Valtoco® via nasal spray. RNS recorded Detections and Long Episodes before and after Valtoco® administration will be compared. This is a pilot study, so all outcomes are exploratory.

Clinical Trial Description

Specific Aim 1: To determine the impact of Valtoco® administration on events recorded by RNS compared to the same time administration of the prior seven days.

Objectives: The investigators will assess the percent change in Detections calculated separately for each hour during the first 8 hours of the post-dose observation period. The number of Detections during each hour of the 8-hour period post dose will be compared to the same hour during the seven comparable 8-hour sessions of the 7-day pre-dose observation period. That is, if the dose was given at 9 AM on day 0, then the mean number of Detections at baseline will be calculated as the mean number of Detections from 9 AM to 10 AM on day -1 through day -7. The percent change in Detections will be calculated as (number of Detections in hour 1 post dose)/(Mean number of Detections in hour 1 on Day -1 through Day -7). The same hourly change will be calculated for each of the 8 hours after dosing. The comparison will be the same hours each day to minimize the hour to hour variability typically seen in these measures.

Hourly histograms generated by the RNS system and stored in the PDMS will be collected. In addition, using "detailed diagnostics" visual analysis of minute-by-minute Detections will be reviewed for obvious patterns of interest for the 8 hours post dosing.

Total number of hours during the 48-hour post-dose observation period where the number of Detections is <50% of the mean hourly Detection rate over the 7-day pre-dose observation period will be calculated.

The number of Long Episodes recorded during the 7-day pre-dose observation period will be compared to the number of Long Episodes during the post-dose 48-hour observation period.

The number of diary-recorded seizures during the post-dose observation period will be recorded.

The investigators will quantify the 2 highest hourly detection rates for the 7-day pre-dose and 48-hour post-dose periods.

The investigators will calculate the number of days required for the daily detection rate to fall within the 90% confidence interval of the 9 am to 5 PM baselines from the 7-day pre-dose baseline.

The investigators will use descriptive statistics for the detection data and Long Episodes for the entire 7-day post dose period.

The investigators will quantify the time course of observable changes in beta activity on the ECoG recorded samples on the day of dosing. ;

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

• NCT number: NCT05273398
• Study type: Interventional
• Source: University of Cincinnati
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2022
• Completion date: November 10, 2022