Search / Trial NCT00001308

Central Mechanisms in Speech Motor Control Studied With H215O PET

Launched by NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS (NIDCD) · Nov 3, 1999

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Trial Information

Current as of July 23, 2024

Terminated

Keywords

Stuttering Tourette's Syndrome Spasmodic Dysphonia Dysarthria Parkinson's Disease Verbal Dyspraxia Aphasia Speech Motor Control

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 constitute...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA FOR ALL SUBJECTS:
  • Ages 18 to 85.
  • Ability to provide informed consent.
  • Must be a Native English speaker by age 2
  • SPECIFIC INCLUSION CRITERIA FOR SELECTED GROUPS OF HEALTHY VOLUNTEERS:
  • Have had training and experience in creative writing
  • Have had training and experience in vocal or instrumental music
  • Have had training and experience in visual arts
  • SPECIFIC INCLUSION CRITERIA FOR POST-STROKE APHASIA SUBJECTS:
  • Had sensorimotor and language deficits following ischemic infarcts.
  • Had stroke at least two weeks ago.
  • SPECIFIC INCLUSION CRITERIA FOR TRAUMATIC BRAIN INJURY SUBJECTS:
  • Diagnosis of TBI
  • At least one month post-injury
  • SPECIFIC INCLUSION CRITERIA FOR STUTTERING SUBJECTS:
  • History of developmental stuttering with symptoms of dysfluency presenting before the age of 13
  • If recovered, history documented by school or medical records.
  • SPECIFIC INCLUSION CRITERIA FOR EPILEPSY SUBJECTS:
  • Ages 18 to 55 years.
  • Failure of seizures to respond to adequate therapy with at least two standard antiepileptic drugs.
  • Willingness to be considered for surgery
  • Fluency in English. Non-native speakers may be included if their fluency is equivalent to that of a native speaker.
  • Must have localization-related epilepsy
  • Must be currently enrolled in Protocol 08-N-0161 to participate in this study
  • EXCLUSION CRITERIA FOR ALL SUBJECTS:
  • Past or present major medical or psychiatric illnesses (DSM-IV criteria) except Post Traumatic Stress Disorder (PTSD) in TBI subjects an anxiety disorder in stuttering subjects
  • Significant abnormalities on the general physical examination unrelated to the stroke or TBI
  • Unable to undergo MRI studies due to pacemakers, aneurysm clips, cochlear implants, shrapnel fragments or a significant history of exposure to small metallic objects which might have become lodged in the tissues of the head or neck or who require hearing aids.
  • Subjects who are pregnant are excluded from the PET and MRI tests in this study.
  • Subjects who are lactating are excluded from the PET tests.
  • Subjects who have or are found to have significant visual agnosia.
  • Subjects who cannot provide informed consent.
  • SPECIFIC EXCLUSION CRITERIA FOR POST-STROKE APHASIA SUBJECTS:
  • More than two prior strokes
  • Concurrent diagnoses of neurodegenerative disorders or vascular dementia
  • Comprehension Aphasia Quotient (AQ) of less than 4 on the Western Aphasia Battery (WAB)
  • SPECIFIC EXCLUSION CRITERIA FOR TRAUMATIC BRAIN INJURY SUBJECTS:
  • For military subjects: Positive screen for Acinetobacter baumannii-calcoaceticus complex (ABC) infection or colonization
  • Severe cognitive impairments as evidenced by scores of less than 7 on the Rancho Los Amigos Scale of Cognitive Functioning and/or less than 76 on the Galveston Orientation and Amnesia Test.
  • For all subjects: Comprehension AQ of less than 4 on the WAB
  • A diagnosis of PTSD, which is almost always found in TBI subjects recruited from the military, will not disquality TBI subjects from participation.
  • SPECIFIC EXCLUSION CRITERIA FOR STUTTERING SUBJECTS:
  • Structural abnormalities on standard clinical (MPRAGE, T2-weighted) MRI scans studies
  • A diagnosis of anxiety dirorder will not disqualify stuttering subjects from participation
  • SPECIFIC EXCLUSION CRITERIA FOR EPILEPSY SUBJECTS:
  • Claustrophobia or anxiety disorders that could be exacerbated by the MRI Scanner
  • Subjects with neurological disorders, in addition to epilepsy such as, stroke, Parkinson s disease), or who have psychiatric diagnoses (, such as, obsessive-compulsive disorder)
  • Patients on Phenobarbital or chronic Benxodiazepines

Attachments

readout_NCT00001308_2024-07-23.pdf

4.5 MB

NCT00001308_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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