Ignite Creation Date:
2024-05-06 @ 7:27 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02535702
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2015-08-28
Brief Title:
Development Of Neuroimaging Methods To Assess The Neurobiology Of Addiction
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Development of Neuroimaging Methods to Assess the Neurobiology of Addiction
Status:
RECRUITING
Status Verified Date:
2024-07-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Abusing alcohol drugs and other substances can cause serious health problems These substances also can affect brain function Researchers want to learn more about brain function by using magnetic resonance imaging MRI This uses a magnetic field and radio waves to take pictures of the brain
Objective
To develop new ways to use MRI to study the brain
Eligibility
Healthy people 18 years of age or older
Design
Participants will be screened with a medical history physical exam and blood and urine tests
They will answer questions about their drug use and psychiatric history They will be asked about family history of alcoholism or drug abuse
Participants will answer questions to see if they can participate in MRI
Participants will have MRI scans The scanner is a metal cylinder in a strong magnetic field Participants will lie on a table that slides in and out of the cylinder A device called a coil may be placed over the head
Each sub-study will include up to 3 different MRI visits Participants can be in multiple sub-studies But they can have only 1 MRI per week and 20 per year
During MRI visits participants may have urine collected They may get another MRI questionnaire
Participants may have a clinical MRI brain scan This may show physical problems in the brain
During some scans participants may perform simple movement memory and thinking tasks
Participants may be connected to a machine to monitor brain activity during the scan Small metal electrodes will be placed on the scalp A gel will be placed in the space between the electrodes and the scalp
Abusing alcohol drugs and other substances can cause serious health problems These substances also can affect brain function Researchers want to learn more about brain function by using magnetic resonance imaging MRI This uses a magnetic field and radio waves to take pictures of the brain
Objective
To develop new ways to use MRI to study the brain
Eligibility
Healthy people 18 years of age or older
Design
Participants will be screened with a medical history physical exam and blood and urine tests
They will answer questions about their drug use and psychiatric history They will be asked about family history of alcoholism or drug abuse
Participants will answer questions to see if they can participate in MRI
Participants will have MRI scans The scanner is a metal cylinder in a strong magnetic field Participants will lie on a table that slides in and out of the cylinder A device called a coil may be placed over the head
Each sub-study will include up to 3 different MRI visits Participants can be in multiple sub-studies But they can have only 1 MRI per week and 20 per year
During MRI visits participants may have urine collected They may get another MRI questionnaire
Participants may have a clinical MRI brain scan This may show physical problems in the brain
During some scans participants may perform simple movement memory and thinking tasks
Participants may be connected to a machine to monitor brain activity during the scan Small metal electrodes will be placed on the scalp A gel will be placed in the space between the electrodes and the scalp
Detailed Description:
Objectives To improve sensitivity as well as spectral and spatiotemporal resolutions in magnetic resonance MR studies assessing structural neurochemical hemodynamic and electrophysiological changes that occur in the human brain during the resting state as well as those that occur in response to novel sensory motor cognitive or emotional stimulation paradigms
Study population We intend to complete studies in 128 healthy volunteers 64 males and 64 females 18 years or older
Design We will conduct pilot studies each with up to 16 subjects to optimize MR pulse sequences andor functional MR imaging fMRI task paradigms pertinent to the theme of Addiction MR pulse sequences andor fMRI task paradigms will be validated against
appropriated gold-standard methodstasks These studies are required to maximize the sensitivity of new imaging techniques and fMRI tasks used for clinical and research applications that take advantage of 3T MRI scanners at NIH If an exploratory study leads to results of interest and if a larger population is necessary to reach statistical significance a separate protocol will be submitted with a priori hypotheses specific study design and power analysis adapted from the pilot studies performed in the present protocol
Outcome parameters Although multiple measures will be collected the primary outcome will be amplitude and reliability of regional-specific BOLD fMRI signals
MRI we will analyze measures such as the amplitude and the reliability of the test-retest measures of fMRI signals functional connectivity metrics tractography between seed and target regions of interest diffusion tensor imaging DTI brain morphometry using
automatic segmentation and voxel-brain morphometry VBM and brain metabolite levels in regions of interest using MR spectroscopy MRS
EEG electroencephalography we will quantify measures such as event or task-related potentials and coherence between sensors or sources located close to the brain areas of interest
Behavioral measures during fMRI we will quantify measures such as reaction times and accuracy using MRI compatible response pads as well as eye movement using MRI compatible eye trackers and self-reports of the study experience ie degree of interest
and motivation and alertness
-Physiological measures During fMRI we will record physiological parameters such as blood pressure skin conductance respiratory frequency or heart rate to interpret outcome measures
Study population We intend to complete studies in 128 healthy volunteers 64 males and 64 females 18 years or older
Design We will conduct pilot studies each with up to 16 subjects to optimize MR pulse sequences andor functional MR imaging fMRI task paradigms pertinent to the theme of Addiction MR pulse sequences andor fMRI task paradigms will be validated against
appropriated gold-standard methodstasks These studies are required to maximize the sensitivity of new imaging techniques and fMRI tasks used for clinical and research applications that take advantage of 3T MRI scanners at NIH If an exploratory study leads to results of interest and if a larger population is necessary to reach statistical significance a separate protocol will be submitted with a priori hypotheses specific study design and power analysis adapted from the pilot studies performed in the present protocol
Outcome parameters Although multiple measures will be collected the primary outcome will be amplitude and reliability of regional-specific BOLD fMRI signals
MRI we will analyze measures such as the amplitude and the reliability of the test-retest measures of fMRI signals functional connectivity metrics tractography between seed and target regions of interest diffusion tensor imaging DTI brain morphometry using
automatic segmentation and voxel-brain morphometry VBM and brain metabolite levels in regions of interest using MR spectroscopy MRS
EEG electroencephalography we will quantify measures such as event or task-related potentials and coherence between sensors or sources located close to the brain areas of interest
Behavioral measures during fMRI we will quantify measures such as reaction times and accuracy using MRI compatible response pads as well as eye movement using MRI compatible eye trackers and self-reports of the study experience ie degree of interest
and motivation and alertness
-Physiological measures During fMRI we will record physiological parameters such as blood pressure skin conductance respiratory frequency or heart rate to interpret outcome measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-AA-0186 | None | None | None |