Cognitive Performance in Healthy VolunteersNCT02437097
The Effect of Aerobic Exercise and Gaming on Cognitive Performance
A study testing Aerobic exercise, Video Gaming and Aerobic exercise and Video Gaming in people with Cognitive Performance in Healthy Volunteers, run by New York Institute of Technology at 1 site in United States.
Trial summary
Many studies have examined the effects of aerobic exercise and playing video games effects on cognitive performance, which results of which have shown to increase cognitive performance. Presently, there is limited research regarding the effects of the combination of gaming and exercise on cognitive performance. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance in Healthy Volunteers
- What is being tested?
- Aerobic exercise, Video Gaming and Aerobic exercise and Video Gaming
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range: 18-30 years
- Good overall health
- Exercise at least two days/week
Who cannot join
- Any cardiopulmonary conditions including asthma within the last 6 months.
- Any major musculoskeletal injuries (i.e. torn ligaments, bone fractures, etc.) over the last 6 months.
- Any other health issues that would interfere with a subject's safety during exercise.
- Any auditory/vestibular impairments.
- Uncorrected visual problems.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Institute of Technology
Old Westbury, New York, 11568
About this study
Many studies have examined the effects of aerobic exercise and playing video games effects on cognitive performance, which results of which have shown to increase cognitive performance. Presently, there is limited research regarding the effects of the combination of gaming and exercise on cognitive performance. The purpose of our study is to investigate the effects of playing video games, aerobic exercise, and a combination of gaming and aerobic exercise on cognitive performance. Forty healthy subjects, males and females (18-30 years old) who perform moderate exercise at least two times a week will comprise our sample. The study will be a randomized clinical trial with four independent variables: playing video games, aerobic exercise, a combination of simultaneous gaming and aerobic exercise and a control condition. Aerobic exercise will be performed at an intensity of 60 to 70% of maximum heart rate on a Monarch Lower Body Ergometer. Brain Age Game: Train Your Brain in Minutes a Day! will be played on Nintendo 3DS. Executive function will be measured using the Stroop test and Trails B pre and posttest. Analysis of variance for Stroop test and Trails B will be used. In the event of significant F statistics, a post hoc test analysis will be used. The investigators hypothesize a combination of aerobic exercise and simultaneous gaming will produce the greatest increase in cognitive performance. Furthermore, these beneficial changes can be utilized in rehabilitation protocols designed to improve cognitive functioning.
Read the detailed description
This study will include 40 subjects, males and females, aged 18-30 years old. Subjects will consist of trained individuals whom log at least two days/week of moderate exercise. The source of participants will come from New York Institute of Technology community. Participants will be selected according to the inclusion/exclusion criteria.Inclusion Criteria:
- Age range: 18-30 years
- Good overall health
- Exercise at least two days/week
Exclusion Criteria:
- Any cardiopulmonary conditions including asthma within the last 6 months.
- Any major musculoskeletal injuries (i.e. torn ligaments, bone fractures, etc.) over the last 6 months.
- Any other health issues that would interfere with a subject's safety during exercise.
- Any auditory/vestibular impairments.
- Uncorrected visual problems.
Dr. Douris will be taking the medical history for each prospective subject in order to evaluate for the presence of any of the exclusion criteria. We will use the Physical Activity Readiness Questionnaire (PAR-Q) and our own medical questionnaire. All volunteers will sign the informed consent before participation in the study.
Each subject will require one hour to be tested and to undertake their specific condition which will be randomly assigned. Upon consent form completion subjects will be instructed on how the Stroop and Trails B tests will be administered. The Stroop tests: the subject will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning). The Trails B test: the subject is instructed to connect a set of 25 dots as fast as possible while maintaining accuracy. This test provides information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Both tests take approximately 5 minutes to administer. They have both been utilized extensively in the literature to measure changes in executive function as a result of exercise. The subjects will also familiarize themselves with the Brain Age game at the time of consent. Detailed instructions for each testing day are as followed: Pre and Post testing of the Stroop and Trails B tests will occur after each of the four conditions:1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Control condition of sitting quietly for 30 minutes. All testing will take place in the School of Health Professions Research Room, Room 507 of the 500 Building.
Acute Bouts of Aerobic Exercise:Participants will perform 30 minutes of cycling at an intensity of 60 to 70% of maximum heart rate based on 220 - their age. The aerobic exercise will utilize a Monarch 818E Monarch Lower Body Ergometer (Monark Exercise, Stockholm, Sweden). Participant's heart rate will be monitored using Polar heart rate monitor.
Acute Bouts of Video Game:Participants will play Brain Age: Train Your Brain in Minutes a Day! on Nintendo 3DS for 30 minutes in a seated resting position.
Acute Bouts of both Aerobic Exercise and Video Games :Participants will perform 30 minutes of cycling at an intensity of 60 to 70% of maximum heart rate based on 220 minus their age on a Monarch ergometer while playing Brain Age: Train Your Brain in Minutes a Day! on a Nintendo 3DS. Participant's heart rate will be monitored using Polar heart rate.
- Being tested
- Aerobic exercise, Video Gaming, Aerobic exercise and Video Gaming, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.
Video GamingOther
The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.
Aerobic exercise and Video GamingOther
The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.
ControlOther
The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Participants will perform 30 minutes of cycling at an intensity of 60 to 70% of maximum heart rate based on 220 - their age. The aerobic exercise will utilize a Monarch 818E Monarch Lower Body Ergometer (Monark Exercise, Stockholm, Sweden). Participant's heart rate will be monitored using Polar heart rate monitor. Receives: Other: Aerobic exercise |
| Video Gaming | Experimental | Participants will play Brain Age: Train Your Brain in Minutes a Day! on Nintendo 3DS for 30 minutes in a seated resting position. Receives: Other: Video Gaming |
| Aerobic Exercise and Video Gaming | Experimental | Participants will perform 30 minutes of cycling at an intensity of 60 to 70% of maximum heart rate based on 220 minus their age on a Monarch ergometer while playing Brain Age: Train Your Brain in Minutes a Day! on a Nintendo 3DS. Participant's heart rate will be monitored using Polar heart rate. Receives: Other: Aerobic exercise and Video Gaming |
| Control | Placebo comparator | Participants will sit quietly for 30 minutes Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Stroop test
: the subject will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning).
Measured: 10 minutes
The Trails B test
: the subject is instructed to connect a set of 25 dots as fast as possible while maintaining accuracy. This test provides information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cognitive Performance in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Douris, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437097
- Sponsor's protocol ID
- BHS-1115
- Status last verified
- Jul 2016
- First submitted
- 5 May 2015
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Leary KC, Pontifex MB, Scudder MR, Brown ML, Hillman CH. The effects of single bouts of aerobic exercise, exergaming, and videogame play on cognitive control. Clin Neurophysiol. 2011 Aug;122(8):1518-25. doi: 10.1016/j.clinph.2011.01.049. Epub 2011 Feb 24.
PubMed 21353635Byun K, Hyodo K, Suwabe K, Ochi G, Sakairi Y, Kato M, Dan I, Soya H. Positive effect of acute mild exercise on executive function via arousal-related prefrontal activations: an fNIRS study. Neuroimage. 2014 Sep;98:336-45. doi: 10.1016/j.neuroimage.2014.04.067. Epub 2014 May 2.
PubMed 24799137Chang YK, Chu CH, Wang CC, Song TF, Wei GX. Effect of acute exercise and cardiovascular fitness on cognitive function: an event-related cortical desynchronization study. Psychophysiology. 2015 Mar;52(3):342-51. doi: 10.1111/psyp.12364. Epub 2014 Oct 13.
PubMed 25308605Yanagisawa H, Dan I, Tsuzuki D, Kato M, Okamoto M, Kyutoku Y, Soya H. Acute moderate exercise elicits increased dorsolateral prefrontal activation and improves cognitive performance with Stroop test. Neuroimage. 2010 May 1;50(4):1702-10. doi: 10.1016/j.neuroimage.2009.12.023. Epub 2009 Dec 16.
PubMed 20006719Nouchi R, Taki Y, Takeuchi H, Hashizume H, Nozawa T, Kambara T, Sekiguchi A, Miyauchi CM, Kotozaki Y, Nouchi H, Kawashima R. Brain training game boosts executive functions, working memory and processing speed in the young adults: a randomized controlled trial. PLoS One. 2013;8(2):e55518. doi: 10.1371/journal.pone.0055518. Epub 2013 Feb 6.
PubMed 23405164
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Exercise and Gaming on Cognitive Performance
- ClinicalTrials.gov ID
- NCT02437097
- Acronym / sponsor ID
- BHS-1115
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many studies have examined the effects of aerobic exercise and playing video games effects on cognitive performance, which results of which have shown to increase cognitive performance. Presently, there is limited research regarding the effects of the combination of gaming and exercise on cognitive performance. The purpose of our study is to investigate the effects of playing video games, aerobic exercise, and a combination of gaming and aerobic exercise on cognitive performance. Forty healthy subjects, males and females (18-30 years old) who perform moderate exercise at least two times a week will comprise our sample. The study will be a randomized clinical trial with four independent variables: playing video games, aerobic exercise, a combination of simultaneous gaming and aerobic exercise and a control condition. Aerobic exercise will be performed at an intensity of 60 to 70% of maximum heart rate on a Monarch Lower Body Ergometer. Brain Age Game: Train Your Brain in Minutes a Day! will be played on Nintendo 3DS. Executive function will be measured using the Stroop test and Trails B pre and posttest. Analysis of variance for Stroop test and Trails B will be used. In the event of significant F statistics, a post hoc test analysis will be used. The investigators hypothesize a combination of aerobic exercise and simultaneous gaming will produce the greatest increase in cognitive performance. Furthermore, these beneficial changes can be utilized in rehabilitation protocols designed to improve cognitive functioning.
Detailed description
This study will include 40 subjects, males and females, aged 18-30 years old. Subjects will consist of trained individuals whom log at least two days/week of moderate exercise. The source of participants will come from New York Institute of Technology community. Participants will be selected according to the inclusion/exclusion criteria.Inclusion Criteria:
- Age range: 18-30 years
- Good overall health
- Exercise at least two days/week
Exclusion Criteria:
- Any cardiopulmonary conditions including asthma within the last 6 months.
- Any major musculoskeletal injuries (i.e. torn ligaments, bone fractures, etc.) over the last 6 months.
- Any other health issues that would interfere with a subject's safety during exercise.
- Any auditory/vestibular impairments.
- Uncorrected visual problems.
Dr. Douris will be taking the medical history for each prospective subject in order to evaluate for the presence of any of the exclusion criteria. We will use the Physical Activity Readiness Questionnaire (PAR-Q) and our own medical questionnaire. All volunteers will sign the informed consent before participation in the study.
Each subject will require one hour to be tested and to undertake their specific condition which will be randomly assigned. Upon consent form completion subjects will be instructed on how the Stroop and Trails B tests will be administered. The Stroop tests: the subject will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning). The Trails B test: the subject is instructed to connect a set of 25 dots as fast as possible while maintaining accuracy. This test provides information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Both tests take approximately 5 minutes to administer. They have both been utilized extensively in the literature to measure changes in executive function as a result of exercise. The subjects will also familiarize themselves with the Brain Age game at the time of consent. Detailed instructions for each testing day are as followed: Pre and Post testing of the Stroop and Trails B tests will occur after each of the four conditions:1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Control condition of sitting quietly for 30 minutes. All testing will take place in the School of Health Professions Research Room, Room 507 of the 500 Building.
Acute Bouts of Aerobic Exercise:Participants will perform 30 minutes of cycling at an intensity of 60 to 70% of maximum heart rate based on 220 - their age. The aerobic exercise will utilize a Monarch 818E Monarch Lower Body Ergometer (Monark Exercise, Stockholm, Sweden). Participant's heart rate will be monitored using Polar heart rate monitor.
Acute Bouts of Video Game:Participants will play Brain Age: Train Your Brain in Minutes a Day! on Nintendo 3DS for 30 minutes in a seated resting position.
Acute Bouts of both Aerobic Exercise and Video Games :Participants will perform 30 minutes of cycling at an intensity of 60 to 70% of maximum heart rate based on 220 minus their age on a Monarch ergometer while playing Brain Age: Train Your Brain in Minutes a Day! on a Nintendo 3DS. Participant's heart rate will be monitored using Polar heart rate.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Other: Aerobic exerciseParticipants will perform 30 minutes of cycling at an intensity of 60 to 70% of maximum heart rate based on 220 - their age. The aerobic exercise will utilize a Monarch 818E Monarch Lower Body Ergometer (Monark Exercise, Stockholm, Sweden). Participant's heart rate will be monitored using Polar heart rate monitor. |
| Video Gaming | Experimental | Other: Video GamingParticipants will play Brain Age: Train Your Brain in Minutes a Day! on Nintendo 3DS for 30 minutes in a seated resting position. |
| Aerobic Exercise and Video Gaming | Experimental | Other: Aerobic exercise and Video GamingParticipants will perform 30 minutes of cycling at an intensity of 60 to 70% of maximum heart rate based on 220 minus their age on a Monarch ergometer while playing Brain Age: Train Your Brain in Minutes a Day! on a Nintendo 3DS. Participant's heart rate will be monitored using Polar heart rate. |
| Control | Placebo comparator | Other: ControlParticipants will sit quietly for 30 minutes |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age range: 18-30 years
- Good overall health
- Exercise at least two days/week
Key exclusion criteria (5 listed)
- Any cardiopulmonary conditions including asthma within the last 6 months.
- Any major musculoskeletal injuries (i.e. torn ligaments, bone fractures, etc.) over the last 6 months.
- Any other health issues that would interfere with a subject's safety during exercise.
- Any auditory/vestibular impairments.
- Uncorrected visual problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseThe research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function. | Other | Aerobic Exercise |
| Video GamingThe research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function. | Other | Video Gaming |
| Aerobic exercise and Video GamingThe research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function. | Other | Aerobic Exercise and Video Gaming |
| ControlThe research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function. | Other | Control |
Primary outcome
The Stroop test
Time frame: 10 minutes
: the subject will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning).
The Trails B test
Time frame: 10 minutes
: the subject is instructed to connect a set of 25 dots as fast as possible while maintaining accuracy. This test provides information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Background: PubMed 21353635O'Leary KC, Pontifex MB, Scudder MR, Brown ML, Hillman CH. The effects of single bouts of aerobic exercise, exergaming, and videogame play on cognitive control. Clin Neurophysiol. 2011 Aug;122(8):1518-25. doi: 10.1016/j.clinph.2011.01.049. Epub 2011 Feb 24.
- Background: PubMed 24799137Byun K, Hyodo K, Suwabe K, Ochi G, Sakairi Y, Kato M, Dan I, Soya H. Positive effect of acute mild exercise on executive function via arousal-related prefrontal activations: an fNIRS study. Neuroimage. 2014 Sep;98:336-45. doi: 10.1016/j.neuroimage.2014.04.067. Epub 2014 May 2.
- Background: PubMed 25308605Chang YK, Chu CH, Wang CC, Song TF, Wei GX. Effect of acute exercise and cardiovascular fitness on cognitive function: an event-related cortical desynchronization study. Psychophysiology. 2015 Mar;52(3):342-51. doi: 10.1111/psyp.12364. Epub 2014 Oct 13.
- Background: PubMed 20006719Yanagisawa H, Dan I, Tsuzuki D, Kato M, Okamoto M, Kyutoku Y, Soya H. Acute moderate exercise elicits increased dorsolateral prefrontal activation and improves cognitive performance with Stroop test. Neuroimage. 2010 May 1;50(4):1702-10. doi: 10.1016/j.neuroimage.2009.12.023. Epub 2009 Dec 16.
- Background: PubMed 23405164Nouchi R, Taki Y, Takeuchi H, Hashizume H, Nozawa T, Kambara T, Sekiguchi A, Miyauchi CM, Kotozaki Y, Nouchi H, Kawashima R. Brain training game boosts executive functions, working memory and processing speed in the young adults: a randomized controlled trial. PLoS One. 2013;8(2):e55518. doi: 10.1371/journal.pone.0055518. Epub 2013 Feb 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise, Video Gaming and Aerobic exercise and Video Gaming in people with Cognitive Performance in Healthy Volunteers, run by New York Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Stroop test (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02437097, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.