HealthyNCT01825096
Simultaneous FMRI and NIRS to Estimate Brain Cerebral Metabolism
An observational study of Healthy, run by Mclean Hospital at 1 site in United States.
Trial summary
The principal advantages of functional magnetic resonance imaging (fMRI) with blood-oxygenation- level-dependent (BOLD) contrast for studying brain function are: non-invasiveness, ubiquitous availability, relatively high spatiotemporal resolution, and the ability to map function over the entire brain. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2015
- Phase
- Observational
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 1 healthy subject will be recruited for the study from the general population to undergo 12 separate study visits.
Who may be able to join
- Male
- 18 to 40 years old
- Physically healthy by self-report
Who cannot join
- Diagnosis of current drug abuse/dependence, including nicotine, as assessed by DSM-IV criteria
- Current diagnosis of Axis I disorder using DSM-IV criteria, or any Axis I disorder within past 5 years
- Current daily use of antipsychotic, antidepressant, or other psychoactive prescription drug, as well as daily use of non-prescription drugs
- Life threatening or unstable medical illness, or one that can create marked change in mental state
- Heavy caffeine use (greater than 300 mg on a regular, daily basis)
- History of seizure disorder
Show all 22Show fewer
- Subjects that report any history or current major medical illness (cardiovascular, pulmonary, psychiatric, or neurological disorders)
- Subjects who have metal in their body or suffer from claustrophobia cannot participate in this research study.
- Additional MR exclusion criteria may include people with:
- Cardiac pacemakers
- Metal clips on blood vessels (also called stents)
- Artificial heart valves
- Artificial arms, hands, legs, etc.
- Brain stimulator devices
- Implanted drug pumps
- Ear implants
- Eye implants or known metal fragments in eyes
- Exposure to shrapnel or metal filings (wounded in military combat, sheet metal workers, welders, and others)
- Other metallic surgical hardware in vital areas
- Certain tattoos with metallic ink (subjects are asked to inform research staff if they have a tattoo)
- Metal Containing Intrauterine Devices (IUDs).
- Certain transdermal (skin) patches such as Transderm Scop (scopolamine for motion sickness).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Modal fMRI/NIRS for Estimation of CMRO2 for Neuroimaging Studies of Drug Abuse and Psychiatric Illness Problems
The principal advantages of functional magnetic resonance imaging (fMRI) with blood-oxygenation- level-dependent (BOLD) contrast for studying brain function are: non-invasiveness, ubiquitous availability, relatively high spatiotemporal resolution, and the ability to map function over the entire brain. Thus, BOLD fMRI is the most widely applied technology to study healthy brain function and pathophysiology associated with disease. In studies of drug abuse and psychiatric illness though, normal assumptions mapping BOLD signals to neurometabolism may be violated. Generally, these effects are ignored, resulting in large study-to-study variability.
Quantitative fMRI (qfMRI) measures metabolism directly and is more suitable for studies of drug abuse and psychiatric illness. However, qfMRI is too complex for routine use. Cerebral metabolism during brain activation during visual stimulation measured with a new fMRI approach that is simple enough for clinical applications will be compared to CMRO2 activation measured using standard qfMRI.
Read the detailed description
Healthy subjects will undergo a single imaging session. During the imaging session, fMRI and simultaneous near-infrared spectroscopy measurements will be made during visual stimulation (e.g., viewing a flashing checkerboard). This is a methods development study focused on comparing a new method for estimating CMRO2 associated with brain activation with the standard fMRI approach for estimating CMRO2.
- Conditions
- Healthy
- Keywords
- cerebral metabolism, functional magnetic resonance imaging, near infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| baseline | No intervention. Participants are scanned at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in brain activity associated with visual stimulation
CMRO2 brain activation in visual cortex associated with visual stimulation
Measured: cross-sectional, start and up to 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Case only
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Nickerson, PhD, Mclean Hospital
- Investigators
- Lisa D Nickerson, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825096
- Sponsor's protocol ID
- 2012p00622
- Status last verified
- Jan 2017
- First submitted
- 27 Mar 2013
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Modal fMRI/NIRS for Estimation of CMRO2 for Neuroimaging Studies of Drug Abuse and Psychiatric Illness Problems
- ClinicalTrials.gov ID
- NCT01825096
- Acronym / sponsor ID
- 2012p00622
- Conditions
- Healthy
- Keywords
- cerebral metabolism, functional magnetic resonance imaging, near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Apr 2013 (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 principal advantages of functional magnetic resonance imaging (fMRI) with blood-oxygenation- level-dependent (BOLD) contrast for studying brain function are: non-invasiveness, ubiquitous availability, relatively high spatiotemporal resolution, and the ability to map function over the entire brain. Thus, BOLD fMRI is the most widely applied technology to study healthy brain function and pathophysiology associated with disease. In studies of drug abuse and psychiatric illness though, normal assumptions mapping BOLD signals to neurometabolism may be violated. Generally, these effects are ignored, resulting in large study-to-study variability.
Quantitative fMRI (qfMRI) measures metabolism directly and is more suitable for studies of drug abuse and psychiatric illness. However, qfMRI is too complex for routine use. Cerebral metabolism during brain activation during visual stimulation measured with a new fMRI approach that is simple enough for clinical applications will be compared to CMRO2 activation measured using standard qfMRI.
Detailed description
Healthy subjects will undergo a single imaging session. During the imaging session, fMRI and simultaneous near-infrared spectroscopy measurements will be made during visual stimulation (e.g., viewing a flashing checkerboard). This is a methods development study focused on comparing a new method for estimating CMRO2 associated with brain activation with the standard fMRI approach for estimating CMRO2.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| baseline | – | –No intervention. Participants are scanned at baseline. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1 healthy subject will be recruited for the study from the general population to undergo 12 separate study visits.
Key inclusion criteria (3 listed)
- Male
- 18 to 40 years old
- Physically healthy by self-report
Key exclusion criteria (22 listed)
- Diagnosis of current drug abuse/dependence, including nicotine, as assessed by DSM-IV criteria
- Current diagnosis of Axis I disorder using DSM-IV criteria, or any Axis I disorder within past 5 years
- Current daily use of antipsychotic, antidepressant, or other psychoactive prescription drug, as well as daily use of non-prescription drugs
- Life threatening or unstable medical illness, or one that can create marked change in mental state
- Heavy caffeine use (greater than 300 mg on a regular, daily basis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in brain activity associated with visual stimulation
Time frame: cross-sectional, start and up to 6 minutes
CMRO2 brain activation in visual cortex associated with visual stimulation
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 5 Jan 2017.
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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.
Lisa D Nickerson, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Mclean Hospital 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 22 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 5 Jan 2017. 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 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 brain activity associated with visual stimulation (time frame: cross-sectional, start and up to 6 minutes). 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 5 Jan 2017.