Motor learning and performance with different levels of oxygen-enriched air

ISRCTN	ISRCTN13209531
DOI	https://doi.org/10.1186/ISRCTN13209531
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Louisiana State University
Funder	Louisiana State University

Submission date: 25/01/2023
Registration date: 31/01/2023
Last edited: 31/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
It is not known whether normobaric 100% oxygen treatment (increasing the fraction of inspired oxygen under normal pressure) improves motor learning. The increase in oxygenated hemoglobin (HbO2) level may be a hub for adaptive processes in the brain and brain networks involved in motor learning and performance since the neural cells are heavily dependent on oxygen supply. The present study aims to investigate whether normobaric 100% oxygen treatment has a positive effect on motor learning and skill acquisition in healthy individuals. If the treatment has a positive effect on motor learning and skill acquisition in healthy adults, the study could be expanded to investigate the effects of normobaric 100% oxygen treatment during rehabilitation practices that aim at regaining motor functions in participants with brain trauma. If this treatment would also be effective, it may prove to be a simple, widely accessible, and potentially cost-effective therapeutic strategy that could be used to improve motor skill recovery in stroke patients or patients with other brain traumas or neurological diseases.

Who can participate?
Healthy young adults aged 18-35 years old

What does the study involve?
The study will test 100 participants. In each age group, one-half of the participants will be treated with 100 % oxygen during a skill acquisition period of a motor learning experiment, and the other half will be treated with regular air.

What are the possible benefits and risks of participating?
There are no direct benefits from participation in the study. However, the information gained from this study will be used to gain insight into how the central nervous system coordinates movements when performing eye-hand coordination tasks. Individuals belonging to the LSU student community may receive extra credit for research participation in one of their classes if available.

No risks are foreseen; participation in the present study would involve no more risk than risks associated with computer tasks performed during daily life. There are no discomforts expected by breathing an altered level of oxygen under normal ambient pressure conditions. You may feel a little discomfort with wearing a nasal cannula. There is the inadvertent risk that anonymity will not be kept. However, every effort will be made to ensure confidentiality is maintained. All data and participant information will be kept separate and on a password-protected computer. Signed consent forms will be kept in a locked cabinet in a locked room.

Where is the study run from?
Louisiana State University (USA)

When is the study starting and how long is it expected to run for?
January 2019 to October 2022

Who is funding the study?
Louisiana State University (LSU) College of Human Sciences and Education (CHSE) Deans' Faculty Research grant

Who is the main contact?
Marc Dalecki, PhD (Associate Professor), mdalecki@lsu.edu

Contact information

Prof Marc Dalecki
Principal investigator

Louisiana State University
School of Kinesiology
College of Human Sciences & Education
112 Long Fieldhouse
Baton Rouge
70803
United States of America

ORCID ID	0000-0003-1359-7312
Phone	+1 225578 6087
Email	mdalecki@lsu.edu

Dr School of Kinesiology College of Human Sciences & Education
Scientific

1246 Pleasant Hall
Baton Rouge
LA 70803
United States of America

Phone	+1 225 578 2036
Email	not@provided.com

Dr School of Kinesiology College of Human Sciences & Education
Public

1246 Pleasant Hall
Baton Rouge
LA 70803
United States of America

Phone	+1 225 578 2036
Email	not@provided.com

Study information

Primary study design	Interventional
Study design	Single-center interventional double-blind randomized controlled trial
Secondary study design	Randomised controlled trial
Participant information sheet	43109_PIS_Summary Sheet.pdf
Scientific title	Boost your brain: Can a simple 100% normobaric oxygen treatment improve human motor learning processes?
Study objectives	An oxygen treatment improves motor learning processes
Ethics approval(s)	Approved 11/02/2020, Human Subjects Institutional Review Board at Louisiana State University (Institutional Review Board, C/o: Dr Dennis Landin, 130 David Boyd Hall, Baton Rouge, LA 70803, USA; +1 225 578 8692; irb@lsu.edu), ref: 4341
Health condition(s) or problem(s) studied	Healthy young adults
Intervention	In our experiment, we provided a 100% normobaric oxygen treatment (5L/min) via a nasal cannula during the adaptation phase of a visuomotor adaptation task. The control group received a similar treatment but with normobaric medical-grade air (AirTr). Participants are randomly assigned to one of two gas treatment groups, an oxygen tank group and the regular air tank group, by Excel function and will undertake a skill acquisition period of a motor learning experiment. Only the experimenter who administered the gas treatment saw which participant was assigned to which treatment group. The other experimenter who guided the participant through the experiment did not know to which treatment group the participant was assigned, and was also not able to see the gas administration, the view was blocked by a wall, as described below. During the motor learning experiment, participants are equipped with a nasal cannula (Salter 1600HF High Flow Nasal Cannula) connected to an oxygen regulator (Oxygen Gas Regulator, CGA-540, Single Stage, Brass, 4 to 80 psi) connected to an oxygen tank (Airgas Medical oxygen (100% oxygen, size 200), or to a regular flow regulator (Regular Gas Regulator, Single Stage, Brass, 4 to 80 psi) connected to a tank with regular air (Airgas Regular Medical Air, 21% oxygen, size 200). The oxygen tank and the regular air tank are both secured in a separate cylinder stand and stored behind a wall outside the participants' sight. A standard bubble humidifier (Salter Labs 6-15 LPM High Flow 350cc Bubble Humidifier) is installed between the nasal cannula and the flow regulator. An air measuring device (BW Honeywell Clip 2 Year O2 Single Gas Detector BWC2-X) is placed in the experiment room to monitor ambient air continuously, and a pulse oximeter with continuous blood oxygen saturation recording function (EMO-80, EMAY) is placed on the dexterity finger of the left hand to record the oxygenated hemoglobin (HbO2) level of the participants during the experiment.
Intervention type	Other
Primary outcome measure(s)	All primary outcome measures were assessed using a digitalized tablet, stylus pen (Wacom Intuos Pro Pen and Touch Tablet), Movalyzer Software (Neuro-Script LLC, Tempe, AZ), and customized Matlab program, and measured continuously for each trial of the motor learning experiment: 1. Initial direction error 2. Path length 3. Reaction time 4. Movement time 5. Correctness rate 6. Endpoint error
Key secondary outcome measure(s)	Blood oxygenation levels measured using a standard pulse oximeter on the left index finger continuously throughout the experiment
Completion date	01/10/2022

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Total final enrolment	100
Key inclusion criteria	Individuals from the community of Baton Rouge, including the college community, who are between the age of 18 and 35 years old.
Key exclusion criteria	1. Do not have a normal or corrected-to-normal vision and/or hearing 2. Unable to use their hands unassisted 3. Psychological, neurological, and/or other altered physical conditions affecting control of the upper dominant limb and/or eyes 4. Pregnancy
Date of first enrolment	12/02/2020
Date of final enrolment	30/09/2022

Locations

Countries of recruitment

United States of America

Study participating centre

Louisiana State University

112 Long Field House
Baton Rouge
70803
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
IPD sharing plan	The datasets generated and/or analyzed during the current study will be published as a supplement to the results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Summary sheet		31/01/2023	No	Yes
Participant information sheet	consent form		31/01/2023	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file			31/01/2023	No	No

Additional files

43109_PIS_consent form.pdf: consent form
43109_PIS_Summary Sheet.pdf: Summary sheet
43109_Protocol.pdf: Protocol file

Editorial Notes

31/01/2023: Trial's existence confirmed by the Institutional Review Board at Louisiana State University.