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Spasmodic DysphoniaNCT00713414

Role of Neurotransmission and Functional CNS Networks in Spasmodic Dysphonia

An observational study of Spasmodic Dysphonia and Focal Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will examine how the brain controls speech in patients with spasmodic dysphonia, a voice disorder that involves involuntary spasms of muscles in the larynx (voice box), causing breaks in speech. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Spasmodic Dysphonia, Focal Dystonia
How many people
37 participants
Where
1 siteUnited States
Study dates
9 Jul 2008to 21 Sep 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 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Healthy research volunteers and adult patients with ADSD and WC will be eligible for the study.
  • Adult patients with ADSD will have clinically documented ADSD established by voice and speech testing and fiberoptic nasolaryngoscopy.
  • Patients will be required to have:
  • Intermittent uncontrolled voice breaks in vowels, liquids (r \& l), semivowels (w \& y) during speech in ADSD (at least 3 voice breaks), or
  • Less prominent symptoms during whisper, singing, falsetto, or shout;
  • Normal voice and vocal fold movement during protective laryngeal functions and emotional phonation, such as cough, laughter, cry.
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  • Adult patients with WC will have clinically documented WC established by history and neurological examination.
  • Controls will be healthy subjects with a negative history of laryngeal, neurological, or psychiatric problems.
  • All participants will be from 21 to 80 years old and right hand dominant.
  • All participants should be able to perform a sequential finger-tapping task for 40 seconds consecutively

Who cannot join

  • Subjects who are incapable of giving an informed consent.
  • Pregnant or breastfeeding women until a time when they are no longer pregnant or breastfeeding.
  • Subjects with past or present medical history of (a) neurological problems, such as stroke, movement disorders (other than SD and WC in the patient group), brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence; (b) psychiatric problems, such as schizophrenia, major and/or bipolar depression, obsessive-compulsive disorder; (c) laryngeal problems, such as vocal fold paralysis, paresis, vocal fold nodules and polyps, carcinoma, chronic laryngitis. (d) ventricular arrhythmias, renal and hepatic insufficiency, vascular headache, or carcinoid syndrome.
  • Patients who are currently taking medications known to affect GABA and dopamine receptor binding. Occasionally, patients report receiving such medication, although dopaminergic and GABA agonist/antagonists are not typically prescribed in these patients.
  • Patients who received treatment with botulinum toxin injections into the laryngeal muscles within the past 3 months.
  • Patients with vocal and hand tremor or muscle tension dysphonia.
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  • Subjects who have tattoos with contraindications to MRI, ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve, etc.) that cannot be removed for the purpose of study participation.
  • Subjects who received previous radiation exposure greater than 5.0 rem per year.
  • WC patients who experience focal hand dystonia at rest.
  • WC patients who have focal hand dystonia associated with trauma or a known neuroanatomic lesion or disease.

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: Role of Neurotransmission and Functional CNS Networks in Spasmodic Dysphonia and Other Focal Dystonias

This study will examine how the brain controls speech in patients with spasmodic dysphonia, a voice disorder that involves involuntary spasms of muscles in the larynx (voice box), causing breaks in speech. Although the causes of spasmodic dysphonia are unknown, recent studies found changes in brain function in patients with the disorder that may play a role in its development.

People between 21 and 80 years of age with adductor spasmodic dysphonia may be eligible for this study. Candidates are screened with the following procedures:

Read more

Medical history and physical examination.

Nasolaryngoscopy to examine the larynx. For this test, the inside of the subject s nose is sprayed with a decongestant and a small, flexible tube called a nasolaryngoscope is passed through the nose to the back of the throat to allow examination of the larynx. The subject may be asked to talk, sing, whistle and say prolonged vowels during the procedure. The nasolaryngoscope is connected to a camera that records the movement of the vocal cords during these tasks.

Voice and speech recording to measure the type and severity of voice disorder. Subjects are asked questions about their voice disorder and their voice is recorded while they repeat sentences and sounds.

Participants undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) of the brain, as follows:

PET: A catheter is placed in a vein in the subject s arm to inject a radioactive substance called a tracer that is detected by the PET scanner and provides information on brain function. [11C]flumazenil is used in one scanning session and [11C]raclopride is used in another. For the scan, the subject lies on a bed that slides in and out of the doughnut-shaped scanner, wearing a custom-molded mask to support the head and prevent it from moving during the scan. For the first scan the subject lies quietly for 60 minutes. For the second scan, the subject lies quietly for 50 minutes and is then asked to say sentences during another 50 minutes. The amount of radiation received in this study equals to a uniform whole-body exposure of 0.9 rem, which is within the dose guideline established by the NIH Radiation Safety Committee for research subjects. The guideline is an effective dose of 5 rem received per year.

MRI: This procedure uses a strong magnetic field and radio waves instead of X-rays to obtain images of the brain. The subject lies on a table that slides into the scanner, a narrow metal cylinder, wearing ear plugs to muffle loud knocking sounds that occur during the scan. Images of the brain structure are obtained while the subject lies still in the machine for 10 minutes. This is followed by functional MRI (fMRI) for 60 minutes, in which pictures are taken while the subject speaks, showing changes in brain regions that are involved in speech production.

Read the detailed description

Spasmodic dysphonia (SD) and writer s cramp (WC) are primary focal dystonias with selective impairment of voluntary control of speaking and writing, respectively. Although the pathophysiology of SD and WC is unknown, dystonia is considered to be a disorder of basal ganglia that leads to secondary cortical and subcortical sensorimotor dysfunction. Results of recent neuroimaging studies have established microstructural abnormalities, as well as alterations of functional activity and neurotransmission within the basal ganglia-thalamo-cortical circuitry during symptom production in these patients. Abnormal functional relationships between these brain regions may play an important role in the pathophysiology of dystonia. However, the organization of functional networks and the neurochemical correlates underpinning their abnormalities have not, to date, been fully investigated. A few pharmacological reports of patients have provided indirect evidence of the contributing role of the major basal ganglia neurotransmitters, >=-aminobutyric acid (GABA) and dopamine, to the pathophysiology of this disorder. We identified decreased D2/D3 receptor binding at rest and abnormal dopamine release during both symptomatic and asymptomatic tasks in SD and WC compared to controls. We also identified altered GABAergic transmission, especially involving the laryngeal and hand sensorimotor cortex. These changes in neurotransmission may, in turn, be coupled with abnormalities of network functional activity in these patients and thus contribute to the pathophysiology of this disorder. There is, therefore, a critical need to further investigate the contribution of dopaminergic transmission via D1-family receptors as well as dopaminergic function of substantia nigra, pars compacta (SNc), in order to fully characterize abnormalities of dopaminergic neurotransmission in this disorder. Filling this knowledge gap is essential for development of effective neuropharmacological treatments for patients with SD and WC, which are limited, to date, to only short-term benefits from injections of botulinum toxin into the affected muscles every 3-4 months for a lifetime.

Objective

The objective of this application is to determine the role played by major basal ganglia neurotransmitters in the pathophysiology of primary focal dystonia. The central hypothesis is that dopaminergic transmission is selectively altered within the nigro-striatal and direct basal ganglia pathways and is correlated with abnormal dopaminergic function within the indirect basal ganglia circuitry in SD and WC patients.

Study Population:

We plan to examine patients with adductor SD (ADSD) compared to two other groups of subjects: (1) patients with another form of task-specific focal dystonia (writer s cramp, WC) and (2) healthy volunteers without history of neurological, psychiatric, or head and neck disorders. The research volunteers may be spouses of persons with SD and WC without a familial relationship.

Design:

This is a natural history study. Using neuroimaging techniques (positron emission tomography (PET), the central hypothesis will be tested by pursuing two specific aims: (1) to map the D1-like dopaminergic receptor binding in SD and WC patients as measured with PET using [11C]NNC-112; (2) to map the nigro-strital dopaminergic function in SD and WC patients as measured with PET using [18F]FDOPA.

Outcome Measures:

These studies will determine neurotransmitter function in patients with ADSD and WC compared to healthy subjects. The proposed research is expected to advance our understanding of the pathophysiology of voluntary motor control of voice and hand movements in diseased individuals as an important step in identifying possible mechanisms for potential neuropharmacological interventions in these patients.

Keywords
Spasmodic Dysphonia, Dystonia, Basal Ganglia, PET Imaging, fMRI, Voice Disorder, Healthy Volunteer, HV
Medical subject headings
Dysphonia, Dystonic Disorders, Dystonia, Voice Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identify GABAergic and dopaminergic transmission in patients with spasmodic dysphonia and healthy subjects

Secondary outcomes (1)
  1. Determine the functional brain networks during speech and at rest in patients with spasmodic dysphonia compared to healthy subjects.

Timeline

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

  1. First posted11 Jul 2008 (estimated)
  2. Study start9 Jul 2008
  3. Study completion21 Sep 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
Observational model
Cohort
Time perspective
Prospective
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00713414
Sponsor's protocol ID
080181
Other IDs
08-N-0181
Status last verified
21 Sep 2016
First submitted
10 Jul 2008
Last updated
5 Jul 2018
Results posted
No

Publications

  • Albin RL, Young AB, Penney JB. The functional anatomy of basal ganglia disorders. Trends Neurosci. 1989 Oct;12(10):366-75. doi: 10.1016/0166-2236(89)90074-x.

    PubMed 2479133
  • Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l.

    PubMed 1695401
  • Ali SO, Thomassen M, Schulz GM, Hosey LA, Varga M, Ludlow CL, Braun AR. Alterations in CNS activity induced by botulinum toxin treatment in spasmodic dysphonia: an H215O PET study. J Speech Lang Hear Res. 2006 Oct;49(5):1127-46. doi: 10.1044/1092-4388(2006/081).

    PubMed 17077220

Questions about this trial

What is this clinical trial studying?

An observational study of Spasmodic Dysphonia and Focal Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 5 Jul 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Identify GABAergic and dopaminergic transmission in patients with spasmodic dysphonia and healthy subjects. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00713414, 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 5 Jul 2018.

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