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NCT01212029 · ClinicalTrials.gov registry record · NA
Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging
A NA study of Cognition, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- NA
- Development phase
- 159
- Enrollment target
- 1
- Study location
NCT01212029: Completed NA study of Cognition, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT01212029 is a NA study of Cognition that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 159 participants, roughly in line with the 167-participant average among 35 other Cognition trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01212029, a NA study of Cognition, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- NA
- Development phase
- 159 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Non-invasive functional near infrared (fNIR) imaging techniques use infrared light to detect changes in blood volume and oxygen levels during brain activity. fNIR is being studied as a possible way to examine the brain activity of individuals who are unable to undergo standard brain function imaging techniques (such as functional magnetic resonance imaging, or fMRI). For instance, war veterans who have iron shrapnel in the body are not able to have fMRI scans, and very young children or children with autism and related disorders are often not able or willing to cooperate long enough in the MRI environment to allow full imaging studies to take place. Researchers are interested in comparing the results of fNIR and fMRI performed on healthy volunteers to determine if fNIR produces similarly accurate results. Objectives: \- To examine the capabilities of non-invasive functional near infrared imaging techniques on healthy volunteers and compare the results with the existing outcomes of functional magnetic resonance imaging. Eligibility: \- Healthy volunteers at least 18 years of age. Design: * Participants will have one study visit. Depending on the complexity of the task, the whole exam will take between 5 minutes and 1 hour to perform. * Participants will be asked to sit as still as possible while wearing a headband that includes light sources and detectors (the fNIR device). * Participants will be asked to perform a set of tasks (e.g., reading sentences or counting numbers in one s head). Data will be collected during these experiments.
Primary Outcome
Prefrontal cortex (PFC) activation is measured in term of change in oxyhemoglobin (O2Hb) using a functional Near-Infrared Spectroscopy (fNIRS) system at a person forehead. Respiratory Sinus Arrhythmia (RSA) is the variation of heart beat in response to breathing. It is calculated as changes in the lengths of interbeat interval as a result of breathing using root mean square successive difference (RMSSD). The relationship between activation of PFC and RSA is quantified as a linear regression co
Conditions Studied
Interventions
- BEHAVIORAL Behavioral measures
- DEVICE fNIRS Devices & Application
- OTHER Physiological measures
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2011-09-08 |
| Est. Completion | 2024-10-02 |
| Phase | NA |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT01212029 record still lists
NCT01212029 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 167-participant average among 35 other Cognition trials with a reported enrollment target.
The record links to 1 condition, with Cognition appearing as the primary indexed condition, and to 3 interventions - of which Behavioral measures is the first listed.
NCT01212029 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01212029 about?
NCT01212029 is a clinical study titled "Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging". Background: \- Non-invasive functional near infrared (fNIR) imaging techniques use infrared light to detect changes in blood volume and oxygen levels during brain activity. fNIR is being studied as a possible way to examine the brain activity of individuals who are unable to undergo standard brain ...
What is the current status of trial NCT01212029?
This trial is currently completed. It is a NA study. The enrollment target is 159 participants. The study started on 2011-09-08. Estimated completion is 2024-10-02.
What conditions does trial NCT01212029 study?
This clinical trial studies the following conditions: Cognition.
What interventions are being tested in trial NCT01212029?
The interventions under investigation include: Behavioral measures (BEHAVIORAL), fNIRS Devices & Application (DEVICE), Physiological measures (OTHER).
Who is sponsoring clinical trial NCT01212029?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01212029 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cognition
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01212029's enrollment target sits among peer trials
159 7th of 35 higher than 29 of 35 other Cognition trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cognition trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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