Health and WellnessNCT02606591
Houston Independent School District (HISD) Yoga Evaluation
A study testing Electroencephalograph, Cognitive Tests and Hair Sample in people with Health and Wellness, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn about how brain activity, cognitive tests (tests of participant's brain function), and stress hormones are related to taking part in a health and wellness program in elementary-aged students. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Health and Wellness
- What is being tested?
- Electroencephalograph, Cognitive Tests and Hair Sample
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2016to 20 Feb 2018
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Fourth and Fifth graders in Houston Independent School District (HISD) schools that are participating in the Sonima Foundation's Health and Wellness Program
- Participant on USD study protocol.
Who cannot join
- Participants who are taking any antipsychotic medications
- Participants with active central nervous system (CNS) disease or encephalopathy
- Participants who have ever been diagnosed with bipolar disorder or schizophrenia
- Participants who have a history of head injury or who have a known seizure activity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Houston Independent School District (HISD) Yoga and Wellness Program Evaluation
The goal of this research study is to learn about how brain activity, cognitive tests (tests of participant's brain function), and stress hormones are related to taking part in a health and wellness program in elementary-aged students.
Read the detailed description
If participant agrees to take part in this study, they will complete an electroencephalograph (EEG -- a test that measures the electrical activity of the brain), cognitive tests, and provide a hair sample shortly after they enter the study and again near the end of the school year.
The testing will take place in a room at participant's school chosen by the teachers. A member of the study staff will walk participant from their classroom and be with them the whole time the testing is taking place and then take them back to their classroom. If the testing is done before or after school, participant will stay with the member of study staff until their parent or guardian comes to pick them up.
During the EEG, researchers will place 19 electrodes on participant's head and 1 or 2 electrodes on each earlobe. Gel will be used to help attach the electrodes. The electrodes will measure and record participant's brain wave activity, similar to the way a doctor listens to their heart beat from the surface of their skin. During the EEG, participant will be also asked to wear headphones and do some simple tests on the computer that measure their abilities to see, hear, and understand information. The EEG will take up to 5 minutes to set up and then 25 minutes for testing.
Participant will also provide a sample of hair, about 75 strands which is like the thickness of a pencil. The hair will tested to measure a stress hormone called cortisol. The hair will be destroyed after study testing.
Data obtained from the hair samples and EEG will be analyzed alongside the data participant is providing our collaborators at the University of San Diego and the Houston Independent School District.
The EEG that is collected for this study is for research purposes only. It is not the same as a "clinical EEG" that is used in medical diagnosis. The EEG that the study staff will collect looks at how the brain functions. It is not designed to look for medical conditions, the way that an MRI or CAT scan would be used. However, if a possible medical condition is suspected, participant will be told to follow up with their medical provider.
Length of Participation:
Participation on this study will be over after participant provides a hair sample, complete the EEG, and complete the cognitive tests the second time near the end of the school year.
This is an investigational study.
Up to 200 participants will be enrolled in this study. All will take part through MD Anderson at their schools.
- Conditions
- Health and Wellness
- Being tested
- Electroencephalograph, Cognitive Tests, Hair Sample
- Keywords
- Electroencephalograph, EEG, Hair sample, Cognitive tests, Cortisol analysis, Brain activity, Stress hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographProcedure or surgery
Also called EEG
EEG performed at beginning and end of school year.
Cognitive TestsBehavioural
During the EEG, participant asked to wear headphones and do some simple tests on the computer that measure their abilities to see, hear, and understand information.
Hair SampleOther
Participants provide a sample of hair at baseline (near the beginning of school), and follow-up (near the end of school). Sample tested to measure cortisol levels.
| Study group | Role | What they receive |
|---|---|---|
| Electroencephalograph (EEG) + Testing | Experimental | Participants complete an electroencephalograph (EEG) cognitive tests, and provide a hair sample shortly after entering the study and again near the end of the school year. Hair sample tested to measure a stress hormone called cortisol. Receives: Procedure: Electroencephalograph; Behavioral: Cognitive Tests; Other: Hair Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Collecting Electroencephalograms (EEGs; for Brain Activity Analysis in Elementary-Aged Children Participating in a Health and Wellness Program
Trial feasible if 50% of students who are enrolled complete the EEG's.
Measured: 9 months
Feasibility of Collecting Hair Samples (for Cortisol Analysis) in Elementary-Aged Children Participating in a Health and Wellness Program
Trial feasible if 50% of students who are enrolled submit hair samples.
Measured: 9 months
Secondary outcomes (1)
Changes in EEG During Each State (Eyes Open, Eyes Closed, and During Cognitive Testing)
Changes in EEG during each state (eyes open, eyes closed, and during cognitive testing) assessed using LORETA EEG analysis of brain function at baseline and the follow-up time point acquired through a Mitstar amplifier using WinEEG software.
Measured: At baseline and at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study start31 Mar 2016
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health and WellnessStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606591
- Sponsor's protocol ID
- PA15-0677
- Status last verified
- Oct 2018
- First submitted
- 11 Nov 2015
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Houston Independent School District (HISD) Yoga and Wellness Program Evaluation
- ClinicalTrials.gov ID
- NCT02606591
- Acronym / sponsor ID
- PA15-0677
- Conditions
- Health and Wellness
- Keywords
- Electroencephalograph, EEG, Hair sample, Cognitive tests, Cortisol analysis, Brain activity, Stress hormones
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 17 Nov 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.
The goal of this research study is to learn about how brain activity, cognitive tests (tests of participant's brain function), and stress hormones are related to taking part in a health and wellness program in elementary-aged students.
Detailed description
If participant agrees to take part in this study, they will complete an electroencephalograph (EEG -- a test that measures the electrical activity of the brain), cognitive tests, and provide a hair sample shortly after they enter the study and again near the end of the school year.
The testing will take place in a room at participant's school chosen by the teachers. A member of the study staff will walk participant from their classroom and be with them the whole time the testing is taking place and then take them back to their classroom. If the testing is done before or after school, participant will stay with the member of study staff until their parent or guardian comes to pick them up.
During the EEG, researchers will place 19 electrodes on participant's head and 1 or 2 electrodes on each earlobe. Gel will be used to help attach the electrodes. The electrodes will measure and record participant's brain wave activity, similar to the way a doctor listens to their heart beat from the surface of their skin. During the EEG, participant will be also asked to wear headphones and do some simple tests on the computer that measure their abilities to see, hear, and understand information. The EEG will take up to 5 minutes to set up and then 25 minutes for testing.
Participant will also provide a sample of hair, about 75 strands which is like the thickness of a pencil. The hair will tested to measure a stress hormone called cortisol. The hair will be destroyed after study testing.
Data obtained from the hair samples and EEG will be analyzed alongside the data participant is providing our collaborators at the University of San Diego and the Houston Independent School District.
The EEG that is collected for this study is for research purposes only. It is not the same as a "clinical EEG" that is used in medical diagnosis. The EEG that the study staff will collect looks at how the brain functions. It is not designed to look for medical conditions, the way that an MRI or CAT scan would be used. However, if a possible medical condition is suspected, participant will be told to follow up with their medical provider.
Length of Participation:
Participation on this study will be over after participant provides a hair sample, complete the EEG, and complete the cognitive tests the second time near the end of the school year.
This is an investigational study.
Up to 200 participants will be enrolled in this study. All will take part through MD Anderson at their schools.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electroencephalograph (EEG) + Testing | Experimental | Procedure: Electroencephalograph, Behavioral: Cognitive Tests, Other: Hair SampleParticipants complete an electroencephalograph (EEG) cognitive tests, and provide a hair sample shortly after entering the study and again near the end of the school year. Hair sample tested to measure a stress hormone called cortisol. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Fourth and Fifth graders in Houston Independent School District (HISD) schools that are participating in the Sonima Foundation's Health and Wellness Program
- Participant on USD study protocol.
Key exclusion criteria (4 listed)
- Participants who are taking any antipsychotic medications
- Participants with active central nervous system (CNS) disease or encephalopathy
- Participants who have ever been diagnosed with bipolar disorder or schizophrenia
- Participants who have a history of head injury or who have a known seizure activity.
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 |
|---|---|---|
| ElectroencephalographAlso: EEGEEG performed at beginning and end of school year. | Procedure or surgery | Electroencephalograph (EEG) + Testing |
| Cognitive TestsDuring the EEG, participant asked to wear headphones and do some simple tests on the computer that measure their abilities to see, hear, and understand information. | Behavioural | Electroencephalograph (EEG) + Testing |
| Hair SampleParticipants provide a sample of hair at baseline (near the beginning of school), and follow-up (near the end of school). Sample tested to measure cortisol levels. | Other | Electroencephalograph (EEG) + Testing |
Primary outcome
Feasibility of Collecting Electroencephalograms (EEGs; for Brain Activity Analysis in Elementary-Aged Children Participating in a Health and Wellness Program
Time frame: 9 months
Trial feasible if 50% of students who are enrolled complete the EEG's.
Feasibility of Collecting Hair Samples (for Cortisol Analysis) in Elementary-Aged Children Participating in a Health and Wellness Program
Time frame: 9 months
Trial feasible if 50% of students who are enrolled submit hair samples.
1 secondary outcome
Changes in EEG During Each State (Eyes Open, Eyes Closed, and During Cognitive Testing)
Time frame: At baseline and at 9 months
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Lorenzo Cohen, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalograph, Cognitive Tests and Hair Sample in people with Health and Wellness, run by M.D. Anderson Cancer Center 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 Oct 2018. 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. 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 was stopped early (reason given: Slow Accrual). Results are not available in the source record.
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?
Feasibility of Collecting Electroencephalograms (EEGs; for Brain Activity Analysis in Elementary-Aged Children Participating in a Health and Wellness Program (time frame: 9 months). 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?
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 31 Oct 2018.