NCT00001308

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 Tourette's syndrome and parkinson's disease.\<TAB\>

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,163

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 1992

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 1992

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
16.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2016

Completed
Last Updated

December 17, 2019

Status Verified

October 6, 2016

First QC Date

November 3, 1999

Last Update Submit

December 14, 2019

Conditions

Keywords

StutteringTourette's SyndromeSpasmodic DysphoniaDysarthriaParkinson's DiseaseVerbal DyspraxiaAphasiaSpeechMotor Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 to 85.
  • Ability to provide informed consent.
  • Must be a Native English speaker by age 2
  • 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
  • Had sensorimotor and language deficits following ischemic infarcts.
  • Had stroke at least two weeks ago.
  • Diagnosis of TBI
  • At least one month post-injury
  • History of developmental stuttering with symptoms of dysfluency presenting before the age of 13
  • If recovered, history documented by school or medical records.
  • 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
  • +3 more criteria

You may not qualify if:

  • 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.
  • 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)
  • 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.
  • Structural abnormalities on standard clinical (MPRAGE, T2-weighted) MRI scans studies
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Alexander GE, DeLong MR, Strick PL. Parallel organization of functionally segregated circuits linking basal ganglia and cortex. Annu Rev Neurosci. 1986;9:357-81. doi: 10.1146/annurev.ne.09.030186.002041. No abstract available.

    PMID: 3085570BACKGROUND
  • Andrews G, Quinn PT, Sorby WA. Stuttering: an investigation into cerebral dominance for speech. J Neurol Neurosurg Psychiatry. 1972 Jun;35(3):414-8. doi: 10.1136/jnnp.35.3.414.

    PMID: 5035315BACKGROUND
  • Bartlett EJ, Brown JW, Wolf AP, Brodie JD. Correlations between glucose metabolic rates in brain regions of healthy male adults at rest and during language stimulation. Brain Lang. 1987 Sep;32(1):1-18. doi: 10.1016/0093-934x(87)90115-5.

    PMID: 3498529BACKGROUND

MeSH Terms

Conditions

Communication DisordersStutteringTourette SyndromeVoice DisordersDysphoniaDysarthriaParkinson DiseaseApraxiasAphasiaSpeech

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersSpeech DisordersLanguage DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesArticulation DisordersParkinsonian DisordersSynucleinopathiesPsychomotor DisordersVerbal BehaviorCommunicationBehavior

Study Officials

  • Allen R Braun, M.D.

    National Institute on Deafness and Other Communication Disorders (NIDCD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

April 28, 1992

Study Completion

October 6, 2016

Last Updated

December 17, 2019

Record last verified: 2016-10-06

Locations