CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 10 enrolled
Drug / intervention
N acetyl cysteine + vagus nerve stimulationcombination
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/NCT04632069
NCT04632069Early Ph 1Completed

N-acetylcysteine Plus Transcutaneous Vagus Nerve Stimulation in Infants of Diabetic Mothers Who Fail Oral Feeding

Medical University of South Carolina·interventional·Posted Nov 17, 2020·Updated Aug 29, 2024

In Brief

A Early Phase 1 clinical trial evaluating N acetyl cysteine + vagus nerve stimulation for Infant of Diabetic Mother and 3 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Infants of diabetic mothers who are failing to learn oral feeding by term age equivalence have greater CNS oxidative stress, which interact to predict poor neuroplasticity response to transcutaneous vagus nerve stimulation paired with oral feeding. We propose treating the oxidative stress in IDM infants prior to initiating taVNS, with an FDA-approved antioxidant (N-acetylcysteine, NAC) to improve CNS oxidative stress, which in turn regulates expression of many genes including BDNF, that may enhance motor learning.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
202120222023202420252026
First PostedNov 17, 2020
Enrollment StartAug 12, 2021
Primary CompletionMar 1, 2024
Study CompletionJul 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.6 years ago

Interventions

N acetyl cysteine + vagus nerve stimulationcombination

NAC x 14 days, taVNS x 10 days