CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04588519
NCT04588519N/ACompleted
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Transcutaneous Auricular Neurostimulation (tAN) to Mitigate Withdrawal Behaviors in Neonates With Opioid Withdrawal

Spark Biomedical, Inc.·interventional·Posted Oct 19, 2020·Updated Dec 28, 2022

In Brief

A clinical study evaluating Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System for Neonatal Abstinence Syndrome. Completed, enrolled 8 participants across 1 site.

Detailed Summary

This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether. Reducing Neonatal Opioid Withdrawal Syndrome (NOWS) symptoms may also help lessen or eliminate the need for opioid medication and shorten the length of the hospital stay. The neurostimulation device, currently called the Roo is a safe form of neurostimulation that uses sticker-like patches worn in and around the ear during the withdrawal period. The patches deliver a small and painless current of electrical pulses to the skin and underlying cranial nerves.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Abstinence Syndrome
CountriesUnited States
CollaboratorsMedical University of South Carolina

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 19, 2020
Enrollment StartMay 30, 2020
Primary CompletionDec 1, 2020
Study CompletionDec 30, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.7 years ago

Interventions

Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) Systemdevice

Spark Roo tAN System programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA.