Simultaneous FMRI and NIRS to Estimate Brain Cerebral Metabolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Mclean Hospital
Sponsor:
Information provided by (Responsible Party):
Lisa Nickerson, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01825096
First received: March 27, 2013
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Multi-Modal fMRI/NIRS for Estimation of CMRO2 for Neuroimaging Studies of Drug Abuse and Psychiatric Illness Problems

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Changes in brain activity associated with visual stimulation [ Time Frame: cross-sectional, start and up to 6 minutes ] [ Designated as safety issue: No ]
    CMRO2 brain activation in visual cortex associated with visual stimulation


Estimated Enrollment: 12
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
baseline
No intervention. Participants are scanned at baseline.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

12 healthy subjects will be recruited for the study will be recruited from the general population

Criteria

Inclusion Criteria:

  • Male or female
  • 18 to 40 years old
  • Physically healthy by self-report

Exclusion Criteria:

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
  • Subjects that report any history or current major medical illness (cardiovascular, pulmonary, psychiatric, or neurological disorders)
  • Subjects who have metal in their body, suffer from claustrophobia or women who are pregnant or currently breast-feeding 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), or Ortho Evra (birth control).

Enrollment:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825096

Locations
United States, Massachusetts
McLean Imaging Center Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Stacey Farmer, BA    617-855-2359    sfarmer@mclean.harvard.edu   
Principal Investigator: Lisa D Nickerson, PhD         
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Lisa D Nickerson, PhD Mclean Hospital
  More Information

No publications provided

Responsible Party: Lisa Nickerson, PhD, Assistant Physicist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01825096     History of Changes
Other Study ID Numbers: 2012p00622
Study First Received: March 27, 2013
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
cerebral metabolism
functional magnetic resonance imaging
near infrared spectroscopy

ClinicalTrials.gov processed this record on October 21, 2014