Using Acute Intermittent Hypoxia to help Traumatic Brain Injury recovery
Safety and Cognitive Effects of Acute Intermittent Hypoxia-Induced Neuroplasticity in Traumatic Brain Injury
This study tests if short periods of reduced oxygen can safely help people recovering from traumatic brain injury improve their memory, thinking, and movement skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04890639 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and preliminary efficacy of Acute Intermittent Hypoxia (AIH) in survivors of traumatic brain injury (TBI). It aims to determine if brief reductions in inhaled oxygen can be safely tolerated and whether AIH has positive effects on memory, cognition, and motor control. Participants will be closely monitored for adverse events, and data will be analyzed to assess improvements in key outcomes at various dose levels. The study is based on evidence suggesting that AIH may promote neuroplasticity in the central nervous system.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who have experienced a first-time mild to moderate traumatic brain injury.
Not a fit: Patients with severe psychiatric disorders, other neurological diagnoses, or severe pulmonary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and improve cognitive and motor functions in TBI patients.
How similar studies have performed: Previous studies have shown promise in using similar approaches to enhance neuroplasticity, although this specific application of AIH is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18-65 years * A first time, mild to moderate traumatic brain injury (TBI) confirmed by medical records * When available, a Glasgow Coma Scale score between 9-15 * Able to use a keyboard * Able to understand and communicate in English * Able to consent independently * Able to leave a research visit with a companion/group transportation * Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study * Not involved in any other research intervention study testing neurobehavioral functioning Exclusion Criteria: * Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability * Severe aphasia, preventing a participant from understanding the protocol and consent form * Pre-existing hypoxic pulmonary disease * Severe hypertension (\>160/100) * Medically documented history of obstructive lung diseases \[e.g., Chronic obstructive pulmonary disease (COPD) or significant asthma\] * Ischemic cardiac disease * Ineligible to undergo MRI or TMS
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Jordan Grafman, PhD — Shirley Ryan AbilityLab
- Study coordinator: Katya Delikishkina, PhD
- Email: kdelikishk@sralab.org
- Phone: 312-238-4579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.