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Communication DisorderNCT00001308

Central Mechanisms in Speech Motor Control Studied With H215O PET

An observational study of Communication Disorder and Healthy, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Communication Disorder, Healthy, Stuttering
How many people
1,163 participants
Where
1 siteUnited States
Study dates
28 Apr 1992to 6 Oct 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Multimodal Studies of Language Production and Comprehension in Normal Volunteers and Patients With Neurologically-Based Language Impairments

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.

Read more

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>

Read the 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.

Keywords
Stuttering, Tourette's Syndrome, Spasmodic Dysphonia, Dysarthria, Parkinson's Disease, Verbal Dyspraxia, Aphasia, Speech, Motor Control
Medical subject headings
Communication Disorders, Stuttering, Tourette Syndrome, Voice Disorders, Dysphonia, Dysarthria, Parkinson Disease, Apraxias

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 1999 (estimated)
  2. Study start28 Apr 1992
  3. Study completion6 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
1,163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001308
Sponsor's protocol ID
920178
Other IDs
92-DC-0178
Status last verified
6 Oct 2016
First submitted
3 Nov 1999
Last updated
17 Dec 2019
Results posted
No

Publications

  • 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.

    PubMed 3085570

  • 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.

    PubMed 5035315

  • 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.

    PubMed 3498529

Questions about this trial

What is this clinical trial studying?

An observational study of Communication Disorder and Healthy, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001308, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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