Acute Intermittent Hypoxia for Traumatic Brain Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Shirley Ryan AbilityLab, Chicago, ILTraumatic Brain Injury+5 MoreAcute Intermittent Hypoxia - Procedure
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying whether it is safe for people with TBI to have their oxygen levels reduced briefly and if doing so has any effect on memory, cognition, and motor control.

Eligible Conditions
  • Traumatic Brain Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 19 Secondary · Reporting Duration: Assessed and reported at the 2-minute, 6-minute, 14-minute, 24-minute, and 30-minute timepoints throughout each hypoxia session

Hour 1
Change in Rey Auditory Verbal Learning Test (RAVLT) scores
Change in Visual Analogue Mood Scale (VAM-S) score
Assessed and reported approximately 45 min after the first and the fourth hypoxia session
Change in Motor Evoked Potentials (MEPs)
Day 24
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
Change in MRI- Resting State
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores
Change in Serial Reaction Time Task (SRTT) score
Change in Trail Making Test (TMT) scores
Change in Word Fluency scores
Day 24
Change in Finger Tapping Test score
Change in Grooved Pegboard Test score
Day 21
Change in Beck Depression Inventory (BDI) score
Change in California Verbal Learning Test (CVLT) score
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score
Change in Trail Making Test (TMT) score
Change in Word Fluency score
Change in intracortical inhibition
Assessed and reported at the 2-minute, 6-minute, 14-minute, 24-minute, and 30-minute timepoints throughout each hypoxia session
Change in Verbal Response to a 10-Item Subjective Symptom Checklist
Change in Verbal Response to a 9-Item Subjective Symptom Checklist
Assessed and reported in real time throughout each 30-minute hypoxia session
Change in Vitals

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

AIH group
1 of 1

Experimental Treatment

16 Total Participants · 1 Treatment Group

Primary Treatment: Acute Intermittent Hypoxia · No Placebo Group · N/A

AIH group
Procedure
Experimental Group · 1 Intervention: Acute Intermittent Hypoxia · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acute Intermittent Hypoxia
2019
N/A
~60

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed and reported at the 2-minute, 6-minute, 14-minute, 24-minute, and 30-minute timepoints throughout each hypoxia session

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,270 Previous Clinical Trials
456,086 Total Patients Enrolled
Shirley Ryan AbilityLabLead Sponsor
174 Previous Clinical Trials
13,700 Total Patients Enrolled
Jordan Grafman, PhDPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
1 Previous Clinical Trials
254 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are not currently participating in any other research study that tests how your brain and behavior work together.

Frequently Asked Questions

What is the ambition of this research endeavor?

"The primary metric of this 30-minute hypoxia session is a change in verbal response to a 10-Item Subjective Symptom Checklist. Secondary outcomes include an alteration in intracortical inhibition, measured through Transcranial Magnetic Stimulation (TMS), and modifications in Visual Analogue Mood Scale (VAM-S) score and California Verbal Learning Test (CVLT) score." - Anonymous Online Contributor

Unverified Answer

How many participants is the research team recruiting to take part in this clinical trial?

"Affirmative, clinicaltrials.gov substantiates that this study is presently recruiting participants. It was first made available on March 15th 2022 and the information was last refreshed on May 10th of the same year. The trial necessitates 16 individuals to be enrolled at a single location." - Anonymous Online Contributor

Unverified Answer

Do I meet the qualifications necessary to participate in this experiment?

"This medical trial is currently seeking 16 participants that have experienced a mild to moderate TBI, ranging in age from 18 to 65. In order for applicants to be accepted into the study they must fulfill additional criteria such as possessing the ability to use a keyboard and communicate fluently in English, being able confirm negative pregnancy status (if applicable), not engaging with any other research initiatives concerning neurobehavioral functioning, and having an available Glasgow Coma Scale score between 9-15." - Anonymous Online Contributor

Unverified Answer

Is there an age restriction for inclusion in this clinical investigation?

"This survey is open to patients aged 18-65. There are additional studies available for those under 18 (190) and over 65 (798)." - Anonymous Online Contributor

Unverified Answer

Is recruitment for this clinical trial still available?

"Affirmative, the information on clinicaltrials.gov indicates that this medical study is presently recruiting patients. Originally posted in mid-March of 2022, with a most recent update from early May 2021; the research team are actively seeking 16 individuals to take part at one site." - 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.