Treatment for Brain Ischemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Medical University of South Carolina, Charleston, SC
Brain Ischemia+4 More
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a novel method of stimulating the vagus nerve may help improve feeding for pre-term infants.

See full description

Eligible Conditions

  • Brain Ischemia
  • Infant Feeding Problems, taVNS
  • Feeding Problems, Infants, Oromotor Dysphagia, Hypoxic Ischemic Encephalopathy, Prematurity, taVNS

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 3 primary outcomes and 1 secondary outcome in patients with Brain Ischemia. Measurement will happen over the course of 10 days.

10 days
white matter tract neuroplasticity
20 days
increase in oral feeding volumes
30 minutes during taVNS paired-feed
bradycardia
discomfort scores

Trial Safety

Trial Design

2 Treatment Groups

active taVNS
1 of 2
sham taVNS
1 of 2
Active Control
Non-Treatment Group

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

active taVNS
Device
We will deliver taVNS via the BabyStrong system, with pulses paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) < perceptual threshold (PT), 500microseconds, 25 Hertz (Hz).The ear electrode will be positioned on left tragus for active taVNS.
sham taVNS
Device
The ear electrode positioned on left tragus as for active taVNS. We will test the PT with active stimulation, and then program a sham setting on the BabyStrong unit to deliver no current after the PT is determined.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 minutes during tavns paired-feed
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 minutes during tavns paired-feed for reporting.

Who is running the study

Principal Investigator
D. D. J.
Prof. Dorothea D. Jenkins, Professor
Medical University of South Carolina

Closest Location

Medical University of South Carolina - Charleston, SC

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Infants born at any gestational age (GA), failing oral feeds after trying to learn feeding for 2 weeks if term, and 4 weeks if preterm
safe to attempt oral feeds every feed without volume limitations by occupational or speech therapists,
clinical team has determined will likely need a G-tube.

Patient Q&A Section

Does anoxia-ischemia, brain run in families?

"Genetic influences may predispose the brain to damage in ischemic conditions, and this may be a possible explanation for the high family incidence seen in this condition." - Anonymous Online Contributor

Unverified Answer

How many people get anoxia-ischemia, brain a year in the United States?

"Approximately 1 million to 2.8 million people in the United States need some sort of emergency and surgical intervention. A number of factors contribute to the occurrence of stroke including atrial fibrillation, hypercholesterolemia, hypertension, and diabetes mellitus. The number of people who require surgical intervention has not shifted significantly in the history of the United States. In a recent study, findings highlights the need for further research to determine the best intervention for people who are hospitalized for anemia of prematurity and stroke in neonatal ICUs." - Anonymous Online Contributor

Unverified Answer

What is anoxia-ischemia, brain?

"The cellular and molecular mechanisms of brain ischemia are relatively well understood. In contrast, there remain unanswered questions about the cellular and molecular pathophysiology of brain ischemia induced by short-term or chronic focal cerebral ischemia." - Anonymous Online Contributor

Unverified Answer

What are the signs of anoxia-ischemia, brain?

"Severe ischemia, which affects most of the brain in an irreversible manner, can last for hours. Severe and prolonged ischemia can cause irreversible injury to the brain even in the setting of short durations of ischemia. Data from a recent study, significant brain injury began at 1:80 of flow reduction and persisted with little resolution for up to 18 hours in the case of 6-minute occlusions. Infarct volume increases, the most accurate way to measure outcome after stroke, was greatest when the duration of ischemia was most severe." - Anonymous Online Contributor

Unverified Answer

What causes anoxia-ischemia, brain?

"Injuries of the brain result in death, even if brain damage is not severe. Brain damage is caused by a cascade triggered by the injury and not by an independent triggering event." - Anonymous Online Contributor

Unverified Answer

What are common treatments for anoxia-ischemia, brain?

"Mild focal brain swelling has a potential to be treated with anti-psychotic drugs. In severe bilateral brain swelling, even mild bilateral brain swelling cannot be expected to be resolved with anti-psychotic drugs, and the use of anti-psychotic drugs is discouraged. In patients with severe bilateral brain swelling or head injury, the medical approach should be supportive." - Anonymous Online Contributor

Unverified Answer

Can anoxia-ischemia, brain be cured?

"The data do not support a clinical cure of brain ischemia following brain hypoxia. The mechanism(s) for cell death, the cell types involved, and the effect on behavioral outcome remain to be determined. The data indicate that brain hypoxia alone does not cause cell death with a significant long-term effect on function. However, it should be recognized that the results may be biased by the limitations imposed by our small sample size and the fact that we selected patients from a tertiary care clinic." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in treatment for therapeutic use?

"Results from a recent paper indicated that, in spite of the presence of many new technologies of neuroscience, the current treatment of neurosurgical patients is still based on a classic paradigm. To get better results, we must discover the mechanisms and to integrate them to create new technologies, which should improve our performance in rehabilitation clinics, rehabilitation and even clinical neurosurgery." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating anoxia-ischemia, brain?

"We have not been able to find any randomized controlled trials for treatment of brain injury by anoxia-ischemia, so we cannot be certain that new or improved therapies have been identified. However, there are some very promising preliminary findings that deserve further study." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving treatment?

"A wide range of clinical trials has been done to study potential drug candidates in clinical PTSD, not yet approved. However, very few patients have received treatments in this area. In future clinical trials involving treatment, we should strive for a thorough analysis of study methodology and reporting: a clear reporting of trial design would provide relevant information about clinical trials." - Anonymous Online Contributor

Unverified Answer

What is the latest research for anoxia-ischemia, brain?

"A new approach may be developed that could be applicable to acute stroke patients, as well as to patients with traumatic brain injury, and these preliminary findings need validation in larger studies." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"In the United States, the most common side effects of AIGS/IH were respiratory failure, renal insufficiency (kidney disease), and cardiac failure. In more than three-quarters of the cases, both respiratory failure and renal insufficiency occurred at the same time, making these events harder to detect in the early phase of treatment. In less than one-third of cases, both cardiac failure and renal insufficiency are present and may precede the respiratory failure." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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