Safety and Cognitive Effects of Acute Intermittent Hypoxia-Induced Neuroplasticity in Traumatic Brain Injury

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is designed to answer questions related to safety and preliminary efficacy of Acute Intermittent Hypoxia (AIH) in Traumatic Brain Injury (TBI) survivors. First, we aim to establish whether brief reductions in inhaled oxygen concentration can be safely tolerated in TBI survivors. Second, we aim to establish whether there are any effects of AIH on memory, cognition, and motor control. Participants will be monitored closely for any adverse events during these experiments. Data will be analyzed to determine if there is an improvement in key outcomes at any dose level.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Shirley Ryan AbilityLab
RECRUITING
Chicago
Contact Information
Primary
Katya Delikishkina, PhD
kdelikishk@sralab.org
312-238-4579
Time Frame
Start Date: 2022-03-15
Estimated Completion Date: 2024-11-01
Participants
Target number of participants: 16
Treatments
Experimental: AIH group
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.).
Authors
Monica Perez
Sponsors
Leads: Shirley Ryan AbilityLab
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov