Voice DisordersNCT00066911
Brain Mapping of Voice Control
An observational study of Voice Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Some voice disorders are caused by uncontrolled muscle actions that affect the larynx or voice box. The purpose of this study is to understand 1) how the brain controls voice production; 2) how changes in sensation within the voice box affect brain control of the voice box; 3) how the central nervous system is… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Disorders
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2003to 5 Nov 2009
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria for normal volunteers are normal vocal function and average health as determined by the staff otolaryngologist. Normal vocal function refers to normal voice quality, a negative history for voice or laryngeal disorders. Persons with significant pulmonary, neurological and psychiatric function will not be recruited. The primary inclusion criteria for the voice disordered groups are a current diagnosis of spasmodic dysphonia (abductor or adductor type), muscular tension dysphonia or voice tremor. These persons will not have pulmonary, neurological or psychiatric disorders or exclusion criteria.
- Intermittent strained hoarseness, uncontrolled voice breaks or changes in pitch are present during vowels, liquids (r \& l) and semi-vowels (w \& y), during speech for adductor SD or prolonged voiceless consonants producing breathy breaks for abductor SD;
- Less prominent symptoms during whisper, singing or falsetto,
- Normal voice and vocal fold movement for protective and emotional laryngeal function, such as cough, laugh or cry;
- A diagnosis of adductor or adductor spasmodic dysphonia based on voice testing and fiberoptic nasolaryngoscopy by a board certified otolaryngologist and Speech-Language Pathologist during the initial interview;
- Exclusion of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist.
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- INCLUSION CRITERIA - for Patients with Muscular Tension Dysphonia:
- Increased phonatory muscle tension in the paralaryngeal and suprahyoid muscles on palpation;
- A consistent hypertonic laryngeal posture for phonation, such as either an anterior-posterior squeeze (pin-hole posture) or ventricular hyper adduction and an absence of SD or vocal tremor as determined by a Speech-Language Pathologist and the staff otolaryngologist;
- Exclusion of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist.
- Vocal tremor during vocalization that primarily involves laryngeal structures;
- Exclusion of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist.
Who cannot join
- Any individual with a history of one or more of the following contraindications will be excluded from the study:
- Airway obstruction, smoking or tobacco use;
- Pulmonary, or neurological disease;
- Pregnancy as reported by the volunteer or a positive pregnancy result from a urine sample obtained on the day of testing;
- Psychiatric disorder, under psychiatric care, or on medication for psychiatric disorders. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, major depression, schizophrenia or a bipolar disorder. A history of a previous episode of minor reactive depression would not exclude a person from participation;
- Speech or hearing problems as determined by medical history and examination by the otolaryngologist. A 30 dB HL hearing screening between 500 and 3000 Hz will be conducted if subjects report difficulty following spoken instructions or significant noise exposure;
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- A reduction in the range of vocal fold movement during non-speech tasks such as whistling suggesting either paralysis or paresis, joint abnormality or neoplasm as determined by videolaryngoscopic examination by the staff otolaryngologist;
- Complete aphonia, a history of airway obstruction or structural abnormalities affect the larynx such as vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, chronic laryngitis as determined by videolaryngoscopic examination by the staff otolaryngologist;
- Individuals having any condition that would present unnecessary risk to them, e.g., claustrophobia.
- Specific contraindications for magnetic resonance imaging include: i) Any implant or surgical clip - implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular implant, aneurysm clip, artificial heart valve, insulin pump, orthopedic pins or prosthesis; ii) Any ferromagnetic foreign body - metal shavings, shrapnel, orthodontic braces, certain tattoos or permanent eye liner; and, iii) Any other implanted device or foreign body not listed above that is possibly ferromagnetic.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Functional Brain Mapping of Laryngeal Sensorimotor Control in Voice Disorders
Some voice disorders are caused by uncontrolled muscle actions that affect the larynx or voice box.
The purpose of this study is to understand 1) how the brain controls voice production; 2) how changes in sensation within the voice box affect brain control of the voice box; 3) how the central nervous system is affected when people have motor or sensory abnormalities that affect the voice box; and 4) whether patients with voice disorders differ from people without voice disorders in the way the brain controls the voice box. By better understanding these concepts, researchers hope to develop improved treatments for patients with voice disorders.
Read more
Forty-five healthy adult volunteers and 90 patients with voice disorders will participate in this study. Participants must be between the ages of 20 and 70. The study will involve two visits to the Clinical Center. During the first visit, participants will undergo a medical history and physical exam. During the second visit, investigators will perform the following procedures on study participants: 1) look at the voice box with a nasolaryngoscope, a fine tube through the nose; 2) use MRI [magnetic resonance imaging] to record brain activity while participants use their voice to speak; 3) changing sensation in the voice box by dripping a topical anesthetic onto the vocal folds; and 4) using MRI to again record brain activity during speech immediately after applying the topical anesthetic.
Participants will receive up to $700 in compensation for their involvement in this study.
Read the detailed description
The neural organization of laryngeal motor and somatosensory function will be investigated in adults with idiopathic voice disorders using functional magnetic resonance imaging. Brain activation will be compared in normal volunteers and patients with spasmodic dysphonia (SD), muscle tension dysphonia (MTD) and vocal tremor. While each voice disorder is characterized by strained vocalization, the disorders are distinguished by other differences in voice symptoms. Accordingly, the brain correlates of vocalization in these disorders may both differ from each other and that of normal vocal function. Because sensory feedback has been identified as a factor in SD, the role of afferent input in vocalization will be investigated by comparing brain activation before and after topical anesthesia of the laryngeal mucosa. The afferent blockade is expected to significantly suppress dysphonic symptoms in SD patients for the duration of the block. The change in symptomatology may be associated with a temporary but significant change in central sensorimotor patterns in these patients. The block is not expected to alter MTD, vocal tremor or normal vocal function. The brain activation changes that accompany symptom relief in SD patients will determine alterations in central neural control that have a role in symptom generation in SD. Identifying these differences in central sensorimotor control between the disorders will provide insight into their differences in pathophysiology.
Objectives:
- To determine if emotional vocalization and linguistic vocalization involve different cortical and sub-cortical functional networks in normal adults.
- To determine if only the brain activation network active for linguistic vocalization network differs between normal controls and dysphonia patients during equivalent voice production effort.
- To determine if patients with dysphonia differ from controls during the performance of non-vocal laryngeal gestures when patients are asymptomatic.
- To determine if a reduction in sensation during topical anesthesia alters linguistic vocalization in dysphonia but not in controls.
- Conditions
- Voice Disorders
- Keywords
- Functional Magnetic Resonance Imaging, Vocalization, Spasmodic Dysphonia, Muscular Tension Dysphonia, Topical Lidocaine, Voice Disorders, Vocal Tremor, Healthy Volunteer, HV
- Medical subject headings
- Voice Disorders, Dysphonia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study start2 Aug 2003
- Primary completion5 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 174 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066911
- Sponsor's protocol ID
- 030260
- Other IDs
- 03-N-0260
- Status last verified
- 5 Nov 2009
- First submitted
- 6 Aug 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Ludlow CL, Schulz GM, Yamashita T, Deleyiannis FW. Abnormalities in long latency responses to superior laryngeal nerve stimulation in adductor spasmodic dysphonia. Ann Otol Rhinol Laryngol. 1995 Dec;104(12):928-35. doi: 10.1177/000348949510401203.
PubMed 7492063Dworkin JP, Meleca RJ, Simpson ML, Garfield I. Use of topical lidocaine in the treatment of muscle tension dysphonia. J Voice. 2000 Dec;14(4):567-74. doi: 10.1016/s0892-1997(00)80012-0.
PubMed 11130113Jurgens U. Neural pathways underlying vocal control. Neurosci Biobehav Rev. 2002 Mar;26(2):235-58. doi: 10.1016/s0149-7634(01)00068-9.
PubMed 11856561
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Brain Mapping of Laryngeal Sensorimotor Control in Voice Disorders
- ClinicalTrials.gov ID
- NCT00066911
- Acronym / sponsor ID
- 030260
- Conditions
- Voice Disorders
- Keywords
- Functional Magnetic Resonance Imaging, Vocalization, Spasmodic Dysphonia, Muscular Tension Dysphonia, Topical Lidocaine, Voice Disorders, Vocal Tremor, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 2 Aug 2003
- Primary completion
- 5 Nov 2009 (actual)
- First posted
- 7 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some voice disorders are caused by uncontrolled muscle actions that affect the larynx or voice box.
The purpose of this study is to understand 1) how the brain controls voice production; 2) how changes in sensation within the voice box affect brain control of the voice box; 3) how the central nervous system is affected when people have motor or sensory abnormalities that affect the voice box; and 4) whether patients with voice disorders differ from people without voice disorders in the way the brain controls the voice box. By better understanding these concepts, researchers hope to develop improved treatments for patients with voice disorders.
Forty-five healthy adult volunteers and 90 patients with voice disorders will participate in this study. Participants must be between the ages of 20 and 70. The study will involve two visits to the Clinical Center. During the first visit, participants will undergo a medical history and physical exam. During the second visit, investigators will perform the following procedures on study participants: 1) look at the voice box with a nasolaryngoscope, a fine tube through the nose; 2) use MRI [magnetic resonance imaging] to record brain activity while participants use their voice to speak; 3) changing sensation in the voice box by dripping a topical anesthetic onto the vocal folds; and 4) using MRI to again record brain activity during speech immediately after applying the topical anesthetic.
Participants will receive up to $700 in compensation for their involvement in this study.
Detailed description
The neural organization of laryngeal motor and somatosensory function will be investigated in adults with idiopathic voice disorders using functional magnetic resonance imaging. Brain activation will be compared in normal volunteers and patients with spasmodic dysphonia (SD), muscle tension dysphonia (MTD) and vocal tremor. While each voice disorder is characterized by strained vocalization, the disorders are distinguished by other differences in voice symptoms. Accordingly, the brain correlates of vocalization in these disorders may both differ from each other and that of normal vocal function. Because sensory feedback has been identified as a factor in SD, the role of afferent input in vocalization will be investigated by comparing brain activation before and after topical anesthesia of the laryngeal mucosa. The afferent blockade is expected to significantly suppress dysphonic symptoms in SD patients for the duration of the block. The change in symptomatology may be associated with a temporary but significant change in central sensorimotor patterns in these patients. The block is not expected to alter MTD, vocal tremor or normal vocal function. The brain activation changes that accompany symptom relief in SD patients will determine alterations in central neural control that have a role in symptom generation in SD. Identifying these differences in central sensorimotor control between the disorders will provide insight into their differences in pathophysiology.
Objectives:
- To determine if emotional vocalization and linguistic vocalization involve different cortical and sub-cortical functional networks in normal adults.
- To determine if only the brain activation network active for linguistic vocalization network differs between normal controls and dysphonia patients during equivalent voice production effort.
- To determine if patients with dysphonia differ from controls during the performance of non-vocal laryngeal gestures when patients are asymptomatic.
- To determine if a reduction in sensation during topical anesthesia alters linguistic vocalization in dysphonia but not in controls.
Study design
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The inclusion criteria for normal volunteers are normal vocal function and average health as determined by the staff otolaryngologist. Normal vocal function refers to normal voice quality, a negative history for voice or laryngeal disorders. Persons with significant pulmonary, neurological and psychiatric function will not be recruited. The primary inclusion criteria for the voice disordered groups are a current diagnosis of spasmodic dysphonia (abductor or adductor type), muscular tension dysphonia or voice tremor. These persons will not have pulmonary, neurological or psychiatric disorders or exclusion criteria.
- Intermittent strained hoarseness, uncontrolled voice breaks or changes in pitch are present during vowels, liquids (r \& l) and semi-vowels (w \& y), during speech for adductor SD or prolonged voiceless consonants producing breathy breaks for abductor SD;
- Less prominent symptoms during whisper, singing or falsetto,
- Normal voice and vocal fold movement for protective and emotional laryngeal function, such as cough, laugh or cry;
- A diagnosis of adductor or adductor spasmodic dysphonia based on voice testing and fiberoptic nasolaryngoscopy by a board certified otolaryngologist and Speech-Language Pathologist during the initial interview;
Key exclusion criteria (10 listed)
- Any individual with a history of one or more of the following contraindications will be excluded from the study:
- Airway obstruction, smoking or tobacco use;
- Pulmonary, or neurological disease;
- Pregnancy as reported by the volunteer or a positive pregnancy result from a urine sample obtained on the day of testing;
- Psychiatric disorder, under psychiatric care, or on medication for psychiatric disorders. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, major depression, schizophrenia or a bipolar disorder. A history of a previous episode of minor reactive depression would not exclude a person from participation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 7492063Ludlow CL, Schulz GM, Yamashita T, Deleyiannis FW. Abnormalities in long latency responses to superior laryngeal nerve stimulation in adductor spasmodic dysphonia. Ann Otol Rhinol Laryngol. 1995 Dec;104(12):928-35. doi: 10.1177/000348949510401203.
- Background: PubMed 11130113Dworkin JP, Meleca RJ, Simpson ML, Garfield I. Use of topical lidocaine in the treatment of muscle tension dysphonia. J Voice. 2000 Dec;14(4):567-74. doi: 10.1016/s0892-1997(00)80012-0.
- Background: PubMed 11856561Jurgens U. Neural pathways underlying vocal control. Neurosci Biobehav Rev. 2002 Mar;26(2):235-58. doi: 10.1016/s0149-7634(01)00068-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voice Disorders, 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 12 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066911, 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 2 Jul 2017.