Viewing Study NCT00001308



Ignite Creation Date: 2024-05-05 @ 10:00 AM
Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001308
Status: TERMINATED
Last Update Posted: 2019-12-17
First Post: 1999-11-03

Brief Title: Central Mechanisms in Speech Motor Control Studied With H215O PET
Sponsor: National Institute on Deafness and Other Communication Disorders NIDCD
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Multimodal Studies of Language Production and Comprehension in Normal Volunteers and Patients With Neurologically-Based Language Impairments
Status: TERMINATED
Status Verified Date: 2016-10-06
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: Positron Emission Tomography PET is a technique used to investigate the functional activity of the brain The PET technique allows doctors to study the normal biochemical and metabolic processes of the central nervous system of normal individuals and patients with neurologic illnesses without physical structural damage to the brain Radioactive water H215O in PET scans permits good visualization of areas of the brain related to speech

Most of the PET scan studies conducted have concentrated on learning about how language is formed and decoded Few studies have been conducted on speech production This study aims to use radioactive water H215O and Positron Emission Tomography PET scan to measure blood flow to different areas of the brain in order to better understand the mechanisms involved in speech motor control

When a region of the brain is active it uses more fuel in the form of oxygen and sugar glucose As the brain uses more fuel it produces more waste products carbon dioxide and water Blood carries fuel to the brain and waste products away from the brain As brain activity increases blood flow to and from the area of activity increases also Knowing these facts researchers can use radioactive chemicals H215O and PET scans to observe what areas of the brain are receiving more blood flow

Researchers will ask patients to perform tasks that will affect speech voice and language At the same time patients will undergo a PET scan The tasks are designed to help researchers observe the blood flow to brain areas associated with voicebox laryngeal functions movement of muscles in the jaw tongue and mouth and other aspects of motor speech

Special studies will be conducted to evaluate how certain therapies and tasks can draw out symptoms in illnesses in which speech and language are affected Results of these tests will be used in other studies to evaluate the neurologic mechanisms of diseases like Tourettes syndrome and parkinsons diseaseTAB
Detailed Description: Objective

The primary objective of this protocol is to use multimodal neuroimaging combining complementary electrophysiological and hemodynamic methods to characterize brain-language relationships in healthy subjects and those with neurological disorders that affect speech and language A secondary objective is to utilize these findings to develop evaluation measures for future treatment studies

Study Populations

We will focus on four neurological disorders that affect language processing post-stroke aphasia traumatic brain injury epilepsy and developmental stuttering Each constitutes a significant clinical problem central to the NIDCD s mission These disorders can impair language at several levels - from its elementary perceptual and motor features the peripheral building blocks of language to higher levels of language formulation including word sentence and narrative processing

Design

We will utilize a set of tasks designed to evaluate language at the levels at which clinical pathology emerges We will combine hemodynamic functional MRI and electrophysiological EEG MEG modalities to capitalize on the superior spatial resolution of the former and temporal resolution of the latter methods Whenever possible the same task paradigms are used with both techniques We will conduct crosssectional sub-studies addressing specific questions in each of the disorders of interest we will also conduct longitudinal sub-studies of recovery and neuroplastic reorganization in post-stroke aphasia

Outcome Measures

Outcome measures include speech-language and psychological tests measures of behavioral performance during scanning and corresponding MRI EEG and MEG data Relationships between these datasets will be evaluated using statistical analytic packages

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
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
92-DC-0178 None None None