Voice DisordersNCT00118586
Neuropathology of Spasmodic Dysphonia
An observational study of Voice Disorders and Spasmodic Dysphonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will look for abnormalities in a brain of persons affected with spasmodic dysphonia, a form of movement disorder that involves involuntary "spasms" of the muscles in the vocal folds causing breaks of speech and affecting voice quality. The causes of this disorder are not known. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Voice Disorders, Spasmodic Dysphonia, Healthy
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2005to 3 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary clinical
Who may be able to join
- Healthy research volunteers and patients with SD, MTD, and VT from 21 years of age will be eligible for the study.
- SD PATIENTS:
- A diagnosis of adductor or abductor SD will be based on voice testing and fiberoptic nasolaryngoscopy conducted during the initial interview by an otolaryngologist and speech-language pathologist according to following criteria:
- Intermittent strained hoarseness, uncontrolled voice breaks or changes in pitch during vowels, liquids (r \& l), semivowels (w \& y), during speech are present in adductor SD, or
- Prolonged voiceless consonants producing breathy breaks are present in abductor SD,
- Less prominent symptoms during whisper, singing or falsetto,
Show all 18Show fewer
- Normal voice and vocal fold movement for protective and emotional laryngeal function, such as cough, laugh or cry.
- Postmortem brain and larynx tissue from SD patients deceased from other than neurological, psychiatric, laryngological causes which would not affect our study as determined by medical history.
- MTD PATIENTS:
- 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 hyperadduction 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.
- VT PATIENTS:
- 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.
- CONTROLS:
- Normal vocal function refers to normal voice quality with a negative history of voice or laryngeal disorders.
- Research volunteers without neurological, psychiatric, otolaryngological problems as determined by medical history and examination by a physician.
Who cannot join
- Pregnant women will be excluded from the study until a time when they are no longer pregnant.
- Any individual with a medical history or postmortem diagnoses of one or more of the following contraindications will be excluded from the study:
- SD, MTD, AND VT PATIENTS:
- Other laryngeal pathologies as determined by medical history and fiberoptic nasolaryngoscopic examination conducted during the initial screening by the otolaryngologist and speech-language pathologist, such as:
- Vocal fold paralysis, paresis, joint abnormality, or neoplasm;
- Vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, or chronic laryngitis;
Show all 19Show fewer
- Swallowing problems; airway obstruction
- Speech problems as determined by medical history and examination by the otolaryngologist and speech-language pathologist.
- Neurological diseases and disorders such as stroke affecting the brain regions of interest, movement disorders (e.g., Huntington disease, chorea, myoclonus, Gilles de la Tourette syndrome, Parkinson's disease, progressive supranuclear palsy, and neuroleptic-induced syndromes), brain tumors, traumatic brain injury with loss of consciousness, genetic diseases of the CNS, chronic infections of the nervous system, ataxias, myopathies, myasthenia gravis, demyelinating diseases, epilepsy, alcoholism, and drug dependence.
- Psychiatric diseases and disorders such as schizophrenia, major and/or bipolar depression, and obsessive-compulsive disorder.
- CONTROLS:
- Laryngeal pathologies as determined by medical history and fiberoptic nasolaryngoscopic examination conducted during the initial screening by the otolaryngologist and speech-language pathologist, such as:
- Spasmodic dysphonia, muscular tension dysphonia, voice tremor;
- Vocal fold paralysis, paresis, joint abnormality, or neoplasm;
- Vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, or chronic laryngitis;
- Swallowing problems;
- Speech problems as determined by medical history and examination by the otolaryngologist and a speech-language pathologist.
- Neurological diseases and disorders such as stroke affecting the brain regions of interest, movement disorders (e.g., Huntington disease, chorea, myoclonus, Gilles de la Tourette syndrome, essential tremor, Parkinson's disease, progressive supranuclear palsy, and neuroleptic-induced syndromes), tumors involving the brain region of interest, genetic diseases of the CNS, traumatic brain injury with loss of consciousness chronic infections of the nervous system, ataxias, myopathies, myasthenia gravis, demyelinating diseases, epilepsy, alcoholism, and drug dependence.
- Psychiatric diseases and disorders such as schizophrenia, major and/or bipolar depression, and obsessive-compulsive disorder.
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: Neuropathological Basis of Spasmodic Dysphonia and Related Voice Disorders
This study will look for abnormalities in a brain of persons affected with spasmodic dysphonia, a form of movement disorder that involves involuntary "spasms" of the muscles in the vocal folds causing breaks of speech and affecting voice quality. The causes of this disorder are not known. The study will compare results of magnetic resonance imaging (MRI) in people with spasmodic dysphonia and in healthy volunteers.
People with adductor or abductor spasmodic dysphonia and healthy volunteers may be eligible for this study. Candidates are screened with a medical history, physical examination, and a test called nasolaryngoscopy. 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 (voice box). During this procedure, the subject is asked to perform tasks such as talking, singing, whistling, and saying prolonged vowels. The nasolaryngoscope is connected to a camera to record the movements of the vocal folds during these tasks.
Read more
Eligible participants then undergo MRI of the brain. MRI uses a strong magnetic field and radio waves instead of x-rays to obtain images of body organs and tissues. For this test, the subject lies on a table that slides into the MRI scanner, a narrow metal cylinder, wearing ear plugs to muffle loud knocking sound that occurs during the scan. During MRI anatomical images of the brain are obtained. Subject may be asked to participate in up to two scanning sessions. Each session takes about 1-1/2 hours.
Participants may also be asked to volunteer for a brain donation program which is optional. Information gained from donated tissue may lead to better treatments and potential cures for spasmodic dysphonia.
Read the detailed description
Spasmodic dysphonia (SD) is a focal dystonia affecting the neural control of the laryngeal musculature for speech production. Although the clinical symptoms of SD have been described, the underlying pathological mechanisms remain unknown. Treatment strategies are of short benefit and expensive.
Muscle tension dysphonia (MTD) is considered a behavioral voice disorder because many cases benefit from behavioral therapy. The etiology of this vocal misuse disorder remains unknown but is not considered neurological and is thought to differ from SD.
Vocal tremor (VT) is a form of benign essential tremor. In less severely affected persons, vocal tremor is action-induced and occurs during vocalization only. In more severe cases, the tremor can be present also during exhalation and whispering and affect other structures, such as the velum and pharynx. This is also considered a neurological disorder but may differ in character from SD. Both these disorders can co-occur with SD but can also occur independently.
The anatomical characteristics of pre- and postmortem brains in patients with SD, MTD and VT and healthy volunteers will be investigated using imaging and neurohistological techniques to provide insight into the pathogenesis of SD. Identification of the neuropathological basis of SD and how it differs from other voice disorders would enhance our understanding of the neurological basis of SD.
OBJECTIVES:
Our objective in this study is to investigate anatomical and morphological characteristics of premortem and postmortem brains from persons with SD, and determine how it differs from other voice disorders such as MTD and VT using magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), and neurohistological techniques.
STUDY POPULATION:
We plan to examine persons referred with a diagnosis of SD, MTD, and VT to confirm whether they have symptoms of the disorder and to identify research volunteers who are without neurological, psychiatric, or head and neck disorders. The research volunteers could be spouses of persons with SD, MTD, and VT without a familial relationship.
DESIGN:
This is a natural history study. In the premortem part of the study persons with SD, MTD, and VT and research volunteers will be screened for eligibility for the study. Brain MRI using a 3T scanner will be performed for volumetric reconstruction of gray matter on the first 60 participants in both the patient and research volunteer groups. In addition, high-resolution MRI using 7T scanner will be obtained to identify focal structural differences on individual basis in the same 20 SD patients compared to 20 controls. DTI will be conducted for visualization of white matter tracts in 25 subjects per group. The remaining subjects will only undergo the screening and anatomical MRI scans prior to brain donation.
In the postmortem phase, the study will employ MRI of the postmortem brain specimens for diagnostic purposes. Brain and laryngeal tissue will be processed histologically to quantify morphological abnormalities between the two groups. Because it is estimated that about 48% of subjects who participate in the main MRI study will also grant consent for brain/larynx donation, maximum of additional 30 subjects per group are to be recruited for the study. Many of the previous patients who have participated in Laryngeal and Speech Section protocols in the past will be contacted to determine if they would be interested in participating.
OUTCOME MEASURES:
- Premortem imaging techniques will determine if there are differences in the brain anatomy of patients with SD compared to MTD, VT and to research volunteers:
- Volumetric reconstruction of gray matter regions involved in voice production;
- Visualization of the white matter tracts between brain regions of interest.
- Postmortem MRI will identify discrepancies between premortem and postmortem brains of the same persons with SD in comparisons to MTD, VT and to research volunteers.
- Microscopic examination of brain sections will determine whether abnormalities can be found in the cortical and subcortical regions involved in voice production in persons with SD that differ from patients with MTD and VT.
- Microscopic examination of the larynx will determine distribution of motor and sensory nerve endings in persons with SD and in patients with MTD and VT and controls.
- Conditions
- Voice Disorders, Spasmodic Dysphonia, Healthy, Movement Disorder, Focal Dystonia
- Keywords
- Neuroanatomy, Brain Damage, Dystonia, Pathology, Brain Imaging, Natural History, Spasmodic Dysphonia, SD, Focal Dystonia, Healthy Volunteer, HV
- Medical subject headings
- Voice Disorders, Dysphonia, Movement Disorders, Dystonic Disorders, Brain Injuries, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Muscle tension dysphonia | Increased phonatory muscle tension in the paralaryngeal and suprahyoid muscles onpalpation | |
| Normal Volunteers | Normal vocal function refers to normal voice quality with a negative history of voice orlaryngeal disorders | |
| Spasmodic dysphonia | A diagnosis of adductor or abductor SD will be based on voice testing and fiberoptic nasolaryngoscopy conducted during the initial interview | |
| Vocal Tremor | Vocal tremor during vocalization that primarily involves laryngeal structures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premortem imaging techniques will determine if there are differences in the brain anatomy of patients with SD compared to MTD, VT andto research volunteers
Premortem imaging techniques will determine if there are differences in the brain anatomy of patients with SD compared to MTD, VT and to research volunteers:a) Volumetric reconstruction of gray matter regions involved in voice production;b) Visualization of the white matter tracts between brain regions of interest.
Measured: on going
Postmortem MRI will identify discrepancies between premortem and postmortem brains of the same persons with SD in comparisons to MTD, VT and to research volunteers
Postmortem MRI will identify discrepancies between premortem and postmortem brains of the same persons with SD in comparisons to MTD, VT and to research volunteers
Measured: after postmortem MRI
Microscopic examination of brain sections will determine whether abnormalities can be found in the cortical and subcortical regions involved in voice production in persons with SD that differ from patients with MTD and VT
Microscopic examination of brain sections will determine whether abnormalities can be found in the cortical and subcortical regions involved in voice production in persons with SD that differ from patients with MTD and VT
Measured: Postmortem
Microscopic examination of the larynx will determine distribution of motor and sensory nerve endings in persons with SD and in patients with MTD and VT and controls
Microscopic examination of the larynx will determine distribution of motor and sensory nerve endings in persons with SD and in patients with MTD and VT and controls
Measured: Postmortem
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study start14 Jul 2005
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
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.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sandra B Martin, Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118586
- Sponsor's protocol ID
- 050189
- Other IDs
- 05-N-0189
- Status last verified
- Aug 2022
- First submitted
- 8 Jul 2005
- Last updated
- 8 Aug 2022
- Results posted
- No
Publications
Altschuler SM, Bao XM, Bieger D, Hopkins DA, Miselis RR. Viscerotopic representation of the upper alimentary tract in the rat: sensory ganglia and nuclei of the solitary and spinal trigeminal tracts. J Comp Neurol. 1989 May 8;283(2):248-68. doi: 10.1002/cne.902830207.
PubMed 2738198Aminoff MJ, Dedo HH, Izdebski K. Clinical aspects of spasmodic dysphonia. J Neurol Neurosurg Psychiatry. 1978 Apr;41(4):361-5. doi: 10.1136/jnnp.41.4.361.
PubMed 650244Aronson AE, Lagerlund TD. Neuroimaging studies do not prove the existence of brain abnormalities in spastic (spasmodic) dysphonia. J Speech Hear Res. 1991 Aug;34(4):801-11. doi: 10.1044/jshr.3404.801. No abstract available.
PubMed 1956188
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathological Basis of Spasmodic Dysphonia and Related Voice Disorders
- ClinicalTrials.gov ID
- NCT00118586
- Acronym / sponsor ID
- 050189
- Conditions
- Voice Disorders, Spasmodic Dysphonia, Healthy, Movement Disorder, Focal Dystonia
- Keywords
- Neuroanatomy, Brain Damage, Dystonia, Pathology, Brain Imaging, Natural History, Spasmodic Dysphonia, SD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 14 Jul 2005 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 11 Jul 2005 (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.
This study will look for abnormalities in a brain of persons affected with spasmodic dysphonia, a form of movement disorder that involves involuntary "spasms" of the muscles in the vocal folds causing breaks of speech and affecting voice quality. The causes of this disorder are not known. The study will compare results of magnetic resonance imaging (MRI) in people with spasmodic dysphonia and in healthy volunteers.
People with adductor or abductor spasmodic dysphonia and healthy volunteers may be eligible for this study. Candidates are screened with a medical history, physical examination, and a test called nasolaryngoscopy. 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 (voice box). During this procedure, the subject is asked to perform tasks such as talking, singing, whistling, and saying prolonged vowels. The nasolaryngoscope is connected to a camera to record the movements of the vocal folds during these tasks.
Eligible participants then undergo MRI of the brain. MRI uses a strong magnetic field and radio waves instead of x-rays to obtain images of body organs and tissues. For this test, the subject lies on a table that slides into the MRI scanner, a narrow metal cylinder, wearing ear plugs to muffle loud knocking sound that occurs during the scan. During MRI anatomical images of the brain are obtained. Subject may be asked to participate in up to two scanning sessions. Each session takes about 1-1/2 hours.
Participants may also be asked to volunteer for a brain donation program which is optional. Information gained from donated tissue may lead to better treatments and potential cures for spasmodic dysphonia.
Detailed description
Spasmodic dysphonia (SD) is a focal dystonia affecting the neural control of the laryngeal musculature for speech production. Although the clinical symptoms of SD have been described, the underlying pathological mechanisms remain unknown. Treatment strategies are of short benefit and expensive.
Muscle tension dysphonia (MTD) is considered a behavioral voice disorder because many cases benefit from behavioral therapy. The etiology of this vocal misuse disorder remains unknown but is not considered neurological and is thought to differ from SD.
Vocal tremor (VT) is a form of benign essential tremor. In less severely affected persons, vocal tremor is action-induced and occurs during vocalization only. In more severe cases, the tremor can be present also during exhalation and whispering and affect other structures, such as the velum and pharynx. This is also considered a neurological disorder but may differ in character from SD. Both these disorders can co-occur with SD but can also occur independently.
The anatomical characteristics of pre- and postmortem brains in patients with SD, MTD and VT and healthy volunteers will be investigated using imaging and neurohistological techniques to provide insight into the pathogenesis of SD. Identification of the neuropathological basis of SD and how it differs from other voice disorders would enhance our understanding of the neurological basis of SD.
OBJECTIVES:
Our objective in this study is to investigate anatomical and morphological characteristics of premortem and postmortem brains from persons with SD, and determine how it differs from other voice disorders such as MTD and VT using magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), and neurohistological techniques.
STUDY POPULATION:
We plan to examine persons referred with a diagnosis of SD, MTD, and VT to confirm whether they have symptoms of the disorder and to identify research volunteers who are without neurological, psychiatric, or head and neck disorders. The research volunteers could be spouses of persons with SD, MTD, and VT without a familial relationship.
DESIGN:
This is a natural history study. In the premortem part of the study persons with SD, MTD, and VT and research volunteers will be screened for eligibility for the study. Brain MRI using a 3T scanner will be performed for volumetric reconstruction of gray matter on the first 60 participants in both the patient and research volunteer groups. In addition, high-resolution MRI using 7T scanner will be obtained to identify focal structural differences on individual basis in the same 20 SD patients compared to 20 controls. DTI will be conducted for visualization of white matter tracts in 25 subjects per group. The remaining subjects will only undergo the screening and anatomical MRI scans prior to brain donation.
In the postmortem phase, the study will employ MRI of the postmortem brain specimens for diagnostic purposes. Brain and laryngeal tissue will be processed histologically to quantify morphological abnormalities between the two groups. Because it is estimated that about 48% of subjects who participate in the main MRI study will also grant consent for brain/larynx donation, maximum of additional 30 subjects per group are to be recruited for the study. Many of the previous patients who have participated in Laryngeal and Speech Section protocols in the past will be contacted to determine if they would be interested in participating.
OUTCOME MEASURES:
- Premortem imaging techniques will determine if there are differences in the brain anatomy of patients with SD compared to MTD, VT and to research volunteers:
- Volumetric reconstruction of gray matter regions involved in voice production;
- Visualization of the white matter tracts between brain regions of interest.
- Postmortem MRI will identify discrepancies between premortem and postmortem brains of the same persons with SD in comparisons to MTD, VT and to research volunteers.
- Microscopic examination of brain sections will determine whether abnormalities can be found in the cortical and subcortical regions involved in voice production in persons with SD that differ from patients with MTD and VT.
- Microscopic examination of the larynx will determine distribution of motor and sensory nerve endings in persons with SD and in patients with MTD and VT and controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Muscle tension dysphonia | – | –Increased phonatory muscle tension in the paralaryngeal and suprahyoid muscles onpalpation |
| Normal Volunteers | – | –Normal vocal function refers to normal voice quality with a negative history of voice orlaryngeal disorders |
| Spasmodic dysphonia | – | –A diagnosis of adductor or abductor SD will be based on voice testing and fiberoptic nasolaryngoscopy conducted during the initial interview |
| Vocal Tremor | – | –Vocal tremor during vocalization that primarily involves laryngeal structures |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary clinical
Key inclusion criteria (18 listed)
- Healthy research volunteers and patients with SD, MTD, and VT from 21 years of age will be eligible for the study.
- A diagnosis of adductor or abductor SD will be based on voice testing and fiberoptic nasolaryngoscopy conducted during the initial interview by an otolaryngologist and speech-language pathologist according to following criteria:
- Postmortem brain and larynx tissue from SD patients deceased from other than neurological, psychiatric, laryngological causes which would not affect our study as determined by medical history.
- 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 hyperadduction and an absence of SD or vocal tremor as determined by a Speech-Language Pathologist and the staff otolaryngologist;
Key exclusion criteria (19 listed)
- Pregnant women will be excluded from the study until a time when they are no longer pregnant.
- Any individual with a medical history or postmortem diagnoses of one or more of the following contraindications will be excluded from the study:
- Other laryngeal pathologies as determined by medical history and fiberoptic nasolaryngoscopic examination conducted during the initial screening by the otolaryngologist and speech-language pathologist, such as:
- Speech problems as determined by medical history and examination by the otolaryngologist and speech-language pathologist.
- Neurological diseases and disorders such as stroke affecting the brain regions of interest, movement disorders (e.g., Huntington disease, chorea, myoclonus, Gilles de la Tourette syndrome, Parkinson's disease, progressive supranuclear palsy, and neuroleptic-induced syndromes), brain tumors, traumatic brain injury with loss of consciousness, genetic diseases of the CNS, chronic infections of the nervous system, ataxias, myopathies, myasthenia gravis, demyelinating diseases, epilepsy, alcoholism, and drug dependence.
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
Premortem imaging techniques will determine if there are differences in the brain anatomy of patients with SD compared to MTD, VT andto research volunteers
Time frame: on going
Premortem imaging techniques will determine if there are differences in the brain anatomy of patients with SD compared to MTD, VT and to research volunteers:a) Volumetric reconstruction of gray matter regions involved in voice production;b) Visualization of the white matter tracts between brain regions of interest.
Postmortem MRI will identify discrepancies between premortem and postmortem brains of the same persons with SD in comparisons to MTD, VT and to research volunteers
Time frame: after postmortem MRI
Postmortem MRI will identify discrepancies between premortem and postmortem brains of the same persons with SD in comparisons to MTD, VT and to research volunteers
Microscopic examination of brain sections will determine whether abnormalities can be found in the cortical and subcortical regions involved in voice production in persons with SD that differ from patients with MTD and VT
Time frame: Postmortem
Microscopic examination of brain sections will determine whether abnormalities can be found in the cortical and subcortical regions involved in voice production in persons with SD that differ from patients with MTD and VT
Microscopic examination of the larynx will determine distribution of motor and sensory nerve endings in persons with SD and in patients with MTD and VT and controls
Time frame: Postmortem
Microscopic examination of the larynx will determine distribution of motor and sensory nerve endings in persons with SD and in patients with MTD and VT and controls
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 8 Aug 2022.
- Background: PubMed 2738198Altschuler SM, Bao XM, Bieger D, Hopkins DA, Miselis RR. Viscerotopic representation of the upper alimentary tract in the rat: sensory ganglia and nuclei of the solitary and spinal trigeminal tracts. J Comp Neurol. 1989 May 8;283(2):248-68. doi: 10.1002/cne.902830207.
- Background: PubMed 650244Aminoff MJ, Dedo HH, Izdebski K. Clinical aspects of spasmodic dysphonia. J Neurol Neurosurg Psychiatry. 1978 Apr;41(4):361-5. doi: 10.1136/jnnp.41.4.361.
- Background: PubMed 1956188Aronson AE, Lagerlund TD. Neuroimaging studies do not prove the existence of brain abnormalities in spastic (spasmodic) dysphonia. J Speech Hear Res. 1991 Aug;34(4):801-11. doi: 10.1044/jshr.3404.801. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Sandra B Martin principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 and Spasmodic Dysphonia, 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 18 inclusion and 19 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 8 Aug 2022. 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?
Premortem imaging techniques will determine if there are differences in the brain anatomy of patients with SD compared to MTD, VT andto research volunteers (time frame: on going). The study lists 4 primary outcomes in all. 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 NCT00118586, 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 8 Aug 2022.