Breast CancerNCT02162329
Effects of Meditation on Cognitive Function and Quality of Life
A study testing Questionnaires, Electroencephalography (EEG) and Magnetic Resonance Imaging (fMRI in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in 2 countries.
Trial summary
The goal of this research study is to test Tibetan meditation as a therapy to teach cancer patients to change their brain functioning and to improve quality of life. Researchers want to compare the cancer patients' outcomes to people who have never had cancer. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaires, Electroencephalography (EEG) and Magnetic Resonance Imaging (fMRI
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Oct 2013to 18 Oct 2022
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stage I - III female breast cancer patients who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment
- Report cognitive impairment since starting chemotherapy as assessed by four questions from the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
- 35 to 65 years old
- Able to read, write and speak English, Spanish, or Portuguese
- Willing to come to MD Anderson Cancer Center (MDACC) or Hospital Israelita Albert Einstein (HIAE) for the meditation sessions and assessment sessions
- Right handed (qEEG database comparison is specific to handedness. By requiring all participants be right handed, we will be consistent across EEG analysis.)
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- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Women with no history of cancer)
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: No history of prior chemotherapy)
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: 35 to 65 years old)
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Able to read, write, and speak English, Spanish, or Portuguese)
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Willing to come to MDACC and HIAE for the assessment session)
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Right handed)
Who cannot join
- Diagnosis of a formal thought disorder (e.g., schizophrenia)
- Any past neurologic insult that is known to affect brain function such as traumatic brain injury, dementia, encephalopathy, etc.
- Mini-Mental State Examination score of 23 or below
- Recurrent cancer
- History of a neurological or psychological disorder that may interfere with the patient's ability to cooperate with study procedures
- Factors contraindicated to fMRI
Show all 15Show fewer
- Any extreme mobility issues (e.g. unable to get in or out of a chair unassisted, extremity issues such as neuropathy that limits physical manipulation of objects
- Regularly practiced meditation (greater than once per week) in the year prior to study enrollment
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Diagnosis of a formal thought disorder (e.g. schizophrenia))
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Mini-Mental State Examination score of 23 or below)
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Undergoing chemotherapy)
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Mini-Mental State Examination score of 23 or below)
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Any extreme mobility issues (e.g. unable to get in or out of a chair unassisted, extremity issues such as neuropathy that limits physical manipulation of objects)
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Primary caretaker of a cancer patient)
- (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Patients who have regularly practiced meditation (greater than once per week) in the year prior to study enrollment)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to test Tibetan meditation as a therapy to teach cancer patients to change their brain functioning and to improve quality of life. Researchers want to compare the cancer patients' outcomes to people who have never had cancer.
Read the detailed description
Tibetan Meditation Program:
During the meditation program, you will learn several concepts such as focus, visualization, and sound. You will have up to 16 classes for 8 weeks. They should take about 60 minutes each.
First Study Visit:
If you choose to take part in this study, you will be asked to fill out several questionnaires. You will be asked questions about your memory and concentration, mood, fatigue, how you have been feeling, and your general quality of life. The forms should take about 30 minutes to complete.
You will complete some computer tests to check your memory and concentration. For example, you will be asked to remember a list of words and then be asked to recall them later. These tests should take about 20 minutes to complete.
You will then have an electroencephalography (EEG) done. An EEG checks a person's brainwaves. During the EEG, a snug cap which contains small electrodes will be placed on your head to measure the electrical patterns coming from the brain. This is like the way a doctor listens to your heart from the surface of your skin. During recording of the EEG, you will be asked to complete 3 tests to check your attention, short-term memory, and levels of emotions. For example, for one test you will use a use a keypad to choose a word's name that is a color (such as if the word "blue" written in the color red, the correct answer would be red).The EEG and tests will take about 45 minutes to one hour.
You will also have a functional magnetic resonance imaging (fMRI) scan of your brain. During the scan, you will lie down on your back with both arms extended by your sides. You will be fitted with earplugs and/or headphones to help dampen the noise caused by the scanner. The lights will also be dimmed. You will then lie still until the scan is over. The scan will take about 20 minutes.
The tests, EEG, and fMRI should take a total of about 90 minutes to complete.
Blood (about 1 tablespoon) will be drawn for tests to measure hormones and your immune system responses. This should take about 15 minutes.
All assessments will be performed at baseline and after the completion of classes.
Study Groups:
After the first study visit, you will be randomly assigned to 1 of 2 study groups. You will have about a 1 out of 2 chance of being assigned to each group. The groups are randomly assigned, but it is also based on other factors such as your age and the status of the disease.
Participants in the first group will take part in a meditation program. You will take part in up to 16 meditation classes for a total of 8 weeks. The meditation sessions may take place on any 2 days of the week at MD Anderson. During the meditation sessions, you will do deep breathing and visualization exercises and produce some sounds like "Ah." Each session will last about 60 minutes. A trained meditation instructor will teach the meditation sessions. Participants will be asked to continue daily meditation practice at home outside of the classes and will be given a CD to guide home practice. All sessions will be videotaped. This is so the researchers can keep track of the quality of the sessions. The audio and video files are digital and will be deleted after all the data are studied.
Participants in the second group will be in a wait-list group. You will continue to receive the standard of care for cancer patients, but you will not take part in the meditation program. You will be given the opportunity to take part in the meditation program and similar measures will be collected from you at similar times as that described below.
All participants must agree not to take part in any other meditation programs for as long as you take part in this study.
Follow-up Study Visit:
Within a week after the last meditation session (8 weeks after baseline), all participants will be asked to fill out a packet of questionnaires (like the ones at the first visit). It should take about 50 minutes to complete all of the questionnaires. You will have some tests to check your memory and concentration, similar to the tests you took at your initial visit. You will have another EEG and fMRI. You will have blood drawn.
After the 8 week follow-up, if you were in the meditation group your participation on this study will be over. If you were in the wait-list group you will be offered the meditation program and you will complete the same questionnaires as before. You will not have any more EEG or fMRI measurements or blood drawn.
You may receive reminder calls for each session and the follow-up study visit.
Length of Study:
If you are in the treatment group, you will be on study for up to 8 weeks. If you are in the waitlist group and decide to take meditation classes after the first 8 weeks, you may be on study for up to 16 weeks.
This is an investigational study.
Up to 140 participants will take part in this study. Up to 10 pilot participants without cancer will be take part in this study. Up to 40 participants without cancer and up to 80 patients will be enrolled. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- Questionnaires, Electroencephalography (EEG), Magnetic Resonance Imaging (fMRI, Meditation Classes
- Keywords
- Breast Cancer, Cognitive function, Questionnaires, Surveys, Electroencephalography, EEG, Magnetic resonance imaging, fMRI, Tibetan meditation, Quality of life, QOL
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
Participants fill out several questionnaires asking questions about memory and concentration, mood, fatigue, how they have been feeling, and general quality of life. The questionnaires should take about 30 minutes to complete.
Meditation Group and Wait-List Group also complete questionnaires at follow up visit.
Electroencephalography (EEG)Procedure or surgery
Also called EEG
Meditation Group and Wait-List Group: Electroencephalography (EEG) performed at baseline and at follow up visit. During EEG, 3 tests to check attention, short-term memory, and levels of emotions.
Healthy Control Group: Electroencephalography (EEG) performed at study visit. During EEG, 3 tests to check attention, short-term memory, and levels of emotions.
Magnetic Resonance Imaging (fMRIProcedure or surgery
Also called MRI
Healthy Control Group: Magnetic resonance imaging (fMRI) scan performed.
Meditation Group and Wait-List Group: Magnetic resonance imaging (fMRI) scan of brain performed at baseline and at follow up visit.
Meditation ClassesBehavioural
Participants take part in up to 16 meditation classes for a total of 8 weeks. All sessions videotaped.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group | Other | Healthy participants fill out several questionnaires asking questions about memory and concentration, mood, fatigue, how they have been feeling, and general quality of life. The questionnaires should take about 30 minutes to complete. Electroencephalography (EEG) and magnetic resonance imaging (fMRI) scan performed. These should take a total of about 90 minutes to complete. Receives: Behavioral: Questionnaires; Procedure: Electroencephalography (EEG); Procedure: Magnetic Resonance Imaging (fMRI |
| Tibetan Meditation Group | Experimental | Participants fill out several questionnaires at baseline, at completion of meditation classes, and at follow up visit. The forms should take about 30 minutes to complete. Participants complete computer tests to check memory and concentration taking about 20 minutes to complete. Electroencephalography (EEG) performed at baseline, at completion of classes, and at follow up visit. Participants have magnetic resonance imaging (fMRI) scan of brain at baseline, at completion of meditation classes, and at follow up visit. Tests, EEG, and fMRI should take a total of about 90 minutes to complete. Participants take part in up to 16 meditation classes for a total of 8 weeks. All sessions videotaped. Receives: Behavioral: Questionnaires; Procedure: Electroencephalography (EEG); Procedure: Magnetic Resonance Imaging (fMRI; Behavioral: Meditation Classes |
| Wait-List Group | Other | Participants fill out several questionnaires at baseline and at follow up visit. The forms should take about 30 minutes to complete. Participants complete computer tests to check memory and concentration taking about 20 minutes to complete. Tests, EEG, and fMRI should take a total of about 90 minutes to complete. Participants receive the standard of care for cancer patients.
After 8 week follow up visit, Wait-List Group offered meditation program. Receives: Behavioral: Questionnaires; Procedure: Electroencephalography (EEG); Procedure: Magnetic Resonance Imaging (fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cognitive Function
Primary analyses based on difference scores of continuous variables measured at baseline and 8 weeks later. T tests or Wilcoxon two-sample tests used, depending on the distribution of the data. Reliable change index (RCI) used for the cognitive tasks. RCI based on standard error of measurement for each assessment and takes into account baseline levels of performance for any participant. A chi-square test used to compare the proportions of participants that fall into each classification in the meditation and control groups.
Measured: Assessed at baseline and 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study start22 Oct 2013
- Primary completion18 Oct 2022
- Study completion18 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT02162329
- Sponsor's protocol ID
- 2012-0156
- Other IDs
- NCI-2015-00469
- Status last verified
- Oct 2022
- First submitted
- 10 Jun 2014
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Meditation on Cognitive Function and Quality of Life
- ClinicalTrials.gov ID
- NCT02162329
- Acronym / sponsor ID
- 2012-0156
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Cognitive function, Questionnaires, Surveys, Electroencephalography, EEG, Magnetic resonance imaging, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 22 Oct 2013 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 12 Jun 2014 (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 test Tibetan meditation as a therapy to teach cancer patients to change their brain functioning and to improve quality of life. Researchers want to compare the cancer patients' outcomes to people who have never had cancer.
Detailed description
Tibetan Meditation Program:
During the meditation program, you will learn several concepts such as focus, visualization, and sound. You will have up to 16 classes for 8 weeks. They should take about 60 minutes each.
First Study Visit:
If you choose to take part in this study, you will be asked to fill out several questionnaires. You will be asked questions about your memory and concentration, mood, fatigue, how you have been feeling, and your general quality of life. The forms should take about 30 minutes to complete.
You will complete some computer tests to check your memory and concentration. For example, you will be asked to remember a list of words and then be asked to recall them later. These tests should take about 20 minutes to complete.
You will then have an electroencephalography (EEG) done. An EEG checks a person's brainwaves. During the EEG, a snug cap which contains small electrodes will be placed on your head to measure the electrical patterns coming from the brain. This is like the way a doctor listens to your heart from the surface of your skin. During recording of the EEG, you will be asked to complete 3 tests to check your attention, short-term memory, and levels of emotions. For example, for one test you will use a use a keypad to choose a word's name that is a color (such as if the word "blue" written in the color red, the correct answer would be red).The EEG and tests will take about 45 minutes to one hour.
You will also have a functional magnetic resonance imaging (fMRI) scan of your brain. During the scan, you will lie down on your back with both arms extended by your sides. You will be fitted with earplugs and/or headphones to help dampen the noise caused by the scanner. The lights will also be dimmed. You will then lie still until the scan is over. The scan will take about 20 minutes.
The tests, EEG, and fMRI should take a total of about 90 minutes to complete.
Blood (about 1 tablespoon) will be drawn for tests to measure hormones and your immune system responses. This should take about 15 minutes.
All assessments will be performed at baseline and after the completion of classes.
Study Groups:
After the first study visit, you will be randomly assigned to 1 of 2 study groups. You will have about a 1 out of 2 chance of being assigned to each group. The groups are randomly assigned, but it is also based on other factors such as your age and the status of the disease.
Participants in the first group will take part in a meditation program. You will take part in up to 16 meditation classes for a total of 8 weeks. The meditation sessions may take place on any 2 days of the week at MD Anderson. During the meditation sessions, you will do deep breathing and visualization exercises and produce some sounds like "Ah." Each session will last about 60 minutes. A trained meditation instructor will teach the meditation sessions. Participants will be asked to continue daily meditation practice at home outside of the classes and will be given a CD to guide home practice. All sessions will be videotaped. This is so the researchers can keep track of the quality of the sessions. The audio and video files are digital and will be deleted after all the data are studied.
Participants in the second group will be in a wait-list group. You will continue to receive the standard of care for cancer patients, but you will not take part in the meditation program. You will be given the opportunity to take part in the meditation program and similar measures will be collected from you at similar times as that described below.
All participants must agree not to take part in any other meditation programs for as long as you take part in this study.
Follow-up Study Visit:
Within a week after the last meditation session (8 weeks after baseline), all participants will be asked to fill out a packet of questionnaires (like the ones at the first visit). It should take about 50 minutes to complete all of the questionnaires. You will have some tests to check your memory and concentration, similar to the tests you took at your initial visit. You will have another EEG and fMRI. You will have blood drawn.
After the 8 week follow-up, if you were in the meditation group your participation on this study will be over. If you were in the wait-list group you will be offered the meditation program and you will complete the same questionnaires as before. You will not have any more EEG or fMRI measurements or blood drawn.
You may receive reminder calls for each session and the follow-up study visit.
Length of Study:
If you are in the treatment group, you will be on study for up to 8 weeks. If you are in the waitlist group and decide to take meditation classes after the first 8 weeks, you may be on study for up to 16 weeks.
This is an investigational study.
Up to 140 participants will take part in this study. Up to 10 pilot participants without cancer will be take part in this study. Up to 40 participants without cancer and up to 80 patients will be enrolled. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | Other | Behavioral: Questionnaires, Procedure: Electroencephalography (EEG), Procedure: Magnetic Resonance Imaging (fMRIHealthy participants fill out several questionnaires asking questions about memory and concentration, mood, fatigue, how they have been feeling, and general quality of life. The questionnaires should take about 30 minutes to complete. Electroencephalography (EEG) and magnetic resonance imaging (fMRI) scan performed. These should take a total of about 90 minutes to complete. |
| Tibetan Meditation Group | Experimental | Behavioral: Questionnaires, Procedure: Electroencephalography (EEG), Procedure: Magnetic Resonance Imaging (fMRI, Behavioral: Meditation ClassesParticipants fill out several questionnaires at baseline, at completion of meditation classes, and at follow up visit. The forms should take about 30 minutes to complete. Participants complete computer tests to check memory and concentration taking about 20 minutes to complete. Electroencephalography (EEG) performed at baseline, at completion of classes, and at follow up visit. Participants have magnetic resonance imaging (fMRI) scan of brain at baseline, at completion of meditation classes, and at follow up visit. Tests, EEG, and fMRI should take a total of about 90 minutes to complete. Participants take part in up to 16 meditation classes for a total of 8 weeks. All sessions videotaped. |
| Wait-List Group | Other | Behavioral: Questionnaires, Procedure: Electroencephalography (EEG), Procedure: Magnetic Resonance Imaging (fMRIParticipants fill out several questionnaires at baseline and at follow up visit. The forms should take about 30 minutes to complete. Participants complete computer tests to check memory and concentration taking about 20 minutes to complete. Tests, EEG, and fMRI should take a total of about 90 minutes to complete. Participants receive the standard of care for cancer patients. After 8 week follow up visit, Wait-List Group offered meditation program. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Stage I - III female breast cancer patients who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment
- Report cognitive impairment since starting chemotherapy as assessed by four questions from the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
- 35 to 65 years old
- Able to read, write and speak English, Spanish, or Portuguese
- Willing to come to MD Anderson Cancer Center (MDACC) or Hospital Israelita Albert Einstein (HIAE) for the meditation sessions and assessment sessions
Key exclusion criteria (15 listed)
- Diagnosis of a formal thought disorder (e.g., schizophrenia)
- Any past neurologic insult that is known to affect brain function such as traumatic brain injury, dementia, encephalopathy, etc.
- Mini-Mental State Examination score of 23 or below
- Recurrent cancer
- History of a neurological or psychological disorder that may interfere with the patient's ability to cooperate with study procedures
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 |
|---|---|---|
| QuestionnairesAlso: SurveysParticipants fill out several questionnaires asking questions about memory and concentration, mood, fatigue, how they have been feeling, and general quality of life. The questionnaires should take about 30 minutes to complete. Meditation Group and Wait-List Group also complete questionnaires at follow up visit. | Behavioural | Healthy Control Group, Tibetan Meditation Group, Wait-List Group |
| Electroencephalography (EEG)Also: EEGMeditation Group and Wait-List Group: Electroencephalography (EEG) performed at baseline and at follow up visit. During EEG, 3 tests to check attention, short-term memory, and levels of emotions. Healthy Control Group: Electroencephalography (EEG) performed at study visit. During EEG, 3 tests to check attention, short-term memory, and levels of emotions. | Procedure or surgery | Healthy Control Group, Tibetan Meditation Group, Wait-List Group |
| Magnetic Resonance Imaging (fMRIAlso: MRIHealthy Control Group: Magnetic resonance imaging (fMRI) scan performed. Meditation Group and Wait-List Group: Magnetic resonance imaging (fMRI) scan of brain performed at baseline and at follow up visit. | Procedure or surgery | Healthy Control Group, Tibetan Meditation Group, Wait-List Group |
| Meditation ClassesParticipants take part in up to 16 meditation classes for a total of 8 weeks. All sessions videotaped. | Behavioural | Tibetan Meditation Group |
Primary outcome
Changes in Cognitive Function
Time frame: Assessed at baseline and 8 weeks after treatment
Primary analyses based on difference scores of continuous variables measured at baseline and 8 weeks later. T tests or Wilcoxon two-sample tests used, depending on the distribution of the data. Reliable change index (RCI) used for the cognitive tasks. RCI based on standard error of measurement for each assessment and takes into account baseline levels of performance for any participant. A chi-square test used to compare the proportions of participants that fall into each classification in the meditation and control groups.
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 20 Oct 2022.
- 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, Electroencephalography (EEG) and Magnetic Resonance Imaging (fMRI in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in 2 countries.
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 12 inclusion and 15 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 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Brazil. 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 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?
Changes in Cognitive Function (time frame: Assessed at baseline and 8 weeks after treatment). 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 20 Oct 2022.