What side effects are associated with this type of intervention?

Acute Intermittent Hypoxia (AIH), which involves brief reductions in inhaled oxygen concentration, is being studied for its safety and efficacy in TBI survivors. Common side effects of treatments involving hypoxia can include dizziness, headaches, nausea, and potential exacerbation of neurological symptoms. More broadly, treatments for TBI, such as medications and rehabilitation therapies, can have side effects like fatigue, cognitive disturbances, and increased risk of infections. It is crucial to monitor patients closely for any adverse events during these treatments.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting the use of Acute Intermittent Hypoxia (AIH) for Traumatic Brain Injury (TBI). Most FDA-approved treatments for TBI focus on managing symptoms and preventing secondary injuries rather than directly addressing the primary injury. These treatments include medications to control pain, reduce inflammation, and prevent seizures. Rehabilitation therapies, including physical, occupational, and speech therapy, are also commonly used to aid recovery. Research is ongoing to explore new therapeutic approaches, including AIH, to improve outcomes for TBI patients.

What other types of research exist?

Promising novel alternatives to AIH for TBI patients include: 1) Hyperbaric Oxygen Therapy (HBOT), which involves breathing pure oxygen in a pressurized environment and has shown potential in enhancing neuroplasticity and cognitive recovery. 2) Transcranial Magnetic Stimulation (TMS), a non-invasive method that uses magnetic fields to stimulate nerve cells in the brain, potentially improving motor function and cognitive abilities. 3) Stem Cell Therapy, which involves the use of stem cells to repair and regenerate damaged brain tissue, showing promise in early clinical trials for improving neurological outcomes. 4) Pharmacological agents such as neuroprotective drugs (e.g., erythropoietin, citicoline) that aim to protect brain cells from further damage and support recovery processes.

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Intermittent Hypoxia for Traumatic Brain Injury (AIH Trial)

N/A

Recruiting

Led By Jordan Grafman, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed and reported at the 2-minute, 6-minute, 14-minute, 24-minute, and 30-minute timepoints throughout each hypoxia session

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if low oxygen therapy is safe and beneficial for stable TBI patients with ongoing issues. This therapy may help their brain cells grow and connect better, improving memory and motor skills.

Who is the study for?

This trial is for adults aged 18-65 who have had a mild to moderate TBI, can communicate in English, and are able to use a keyboard. They should not be part of another neurobehavioral study and women must confirm they're not pregnant. Excluded are those with certain heart or lung diseases, severe psychiatric disorders, learning disabilities, inability to undergo MRI or TMS, or severe hypertension.

What is being tested?

The trial tests Acute Intermittent Hypoxia (AIH) on TBI survivors to see if brief periods of lower oxygen levels are safe and if they improve memory, cognition, and motor control. Participants' reactions will be closely watched during the experiments.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse events which could include discomfort from reduced oxygen levels or potential impacts on breathing given the nature of AIH.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed and reported at the 2-minute, 6-minute, 14-minute, 24-minute, and 30-minute timepoints throughout each hypoxia session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed and reported at the 2-minute, 6-minute, 14-minute, 24-minute, and 30-minute timepoints throughout each hypoxia session

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed and reported at the 2-minute, 6-minute, 14-minute, 24-minute, and 30-minute timepoints throughout each hypoxia session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Verbal Response to a 9-Item Subjective Symptom Checklist

Change in Vitals

Secondary study objectives

Change in Beck Depression Inventory (BDI-II) score

Change in California Verbal Learning Test (CVLT-II) scores

Change in Effort Expenditure for Rewards Task (EEfRT) score

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AIH groupExperimental Treatment1 Intervention

Hypoxia will be administered via a specialized face mask attached to a gas mixing device (HYP123, Hypoxico Inc.), which controls oxygen content in inhaled air. The hypoxia administering unit will be manually adjusted to supply O2 at the target level for a given session (approximately 21%-normal room air, 17%, 13%, and 9% respectively). Each session will include 15 cycles of hypoxia, each lasting up to 60 seconds, interspersed with up to 90-second normoxic episodes. An oxygen monitor will continuously measure and record the fraction of inspired oxygen delivered (MAX-250E, Maxtec Inc.).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acute Intermittent Hypoxia

2019

N/A

~160

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Traumatic Brain Injury (TBI) aim to stabilize the patient and prevent secondary brain damage. Acute Intermittent Hypoxia (AIH), which involves brief reductions in inhaled oxygen concentration, is being studied for its potential to stimulate adaptive neuroplasticity. This process can enhance neural connectivity and function, potentially improving memory, cognition, and motor control in TBI patients. Other treatments focus on maintaining cerebral perfusion, managing intracranial pressure, and preventing secondary ischemic injuries, which are essential for minimizing further brain damage and promoting recovery.