Spasmodic DysphoniaSD-VTSNCT03746509
Laryngeal Vibration for Spasmodic Dysphonia
A study testing Laryngeal Vibration (Treatment) and Laryngeal Vibration (Comparator) in people with Spasmodic Dysphonia, run by University of Minnesota at 1 site in United States.
Trial summary
The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of people with spasmodic dysphonia (SD). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spasmodic Dysphonia
- What is being tested?
- Laryngeal Vibration (Treatment) and Laryngeal Vibration (Comparator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2019to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of adductor SD for a minimum of 6 months with documented symptom relief after botox injection
Who cannot join
- abductor SD
- patients with other voice disorders such as muscle tension dysphonia that share some of the symptomology with SD
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Laryngeal Vibration as a Non-invasive Treatment for Spasmodic Dysphonia
The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of people with spasmodic dysphonia (SD). This research addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with limited treatment options. A successful completion of the proposed work will be an important step in advancing laryngeal VTS as a therapeutic intervention for improving the voice symptoms in SD. Specifically, the scientific yield by achieving the specific aims is threefold: First, it will elucidate the unknown neurophysiological mechanism behind laryngeal VTS by documenting the neural changes associated with VTS. Second, it will establish that VTS can improve voice quality in SD. Third, by documenting that laryngeal VTS yields long-term benefits on voice quality in SD patients, it would provide a solid basis for a clinical trial that needs to address open questions on optimal dosage and duration of VTS-based voice therapy, the magnitude of the therapeutic effect across adductor and abductor SD and its long term efficacy.
Read the detailed description
Spasmodic dysphonia (SD) is a rare voice disorder that develops spontaneously during midlife. Patients with SD typically have a strained or choked speech and report that is takes an exhausting effort to speak. The involuntary spasms of the laryngeal musculature that give rise to these symptoms almost always occur during speech. Progression is gradual in the first year and then becomes chronic for life. The cause of spasmodic dysphonia is unknown, but SD is considered to be a form of task-specific focal dystonia (FD). More women than men are affected. Current therapeutic options are limited. SD does not respond to behavioral speech therapy. It is treated primarily with Botulinum toxin injections (Botox), which provides temporary symptom relief to some, but is not well tolerated by all SD patients. At present, there is no cure for SD.
There is convergent evidence that FD is associated with kinaesthetic deficits that are also manifest in non-dystonic musculature indicating that while the motor symptoms of dystonia are focal, the associated somatosensory deficit is general. Recent work from our group (NIH 1R21DC011841) confirmed upper limb proprioceptive deficits in SD demonstrating that an underlying somatosensory deficit is also a feature of SD. In our assessment this finding opens an avenue for a missing behavioral treatment for SD. Specifically, the investigators suggest that vibro-tactile stimulation (VTS) could be the suitable tool, given that it is known to alter afferent signals from the vibrated mechanoreceptors in muscles and skin. The approach seeks to show that VTS represents a non-invasive form of neuromodulation that induces measurable improvements in the speech of SD patients. Given that SD, like other FDs, is associated with abnormally increased cortical excitation and heightened levels of neuronal synchronization, the investigators put forward that VTS can reduce sensorimotor cortical excitation in SD by desynchronizing motor cortical neuron activity as has been shown in cervical dystonia. Technically, newly available light-weight, wearable low-voltage vibrators offer, for the first time, the possibility to apply laryngeal VTS outside a controlled laboratory environment, which would be imperative for the technology to be clinically useful. In general, one needs to demonstrate that a) VTS induces measurable improvements in voice quality, b) that it induces measurable changes in somatosensory and motor cortical activation that would provide insight into the underlying neural mechanism of its potential effectiveness. Thus, the proposal has the following specific aims:
- Demonstrate that a one-time, prolonged application of VTS produces acute improvements in SD voice quality that are retained up to 60 minutes past cessation of VTS. A pre- and post-training comparison showing significant voice improvements in the SD group as measured by self-report (Effort Scale), clinical assessment (Consensus Auditory-Perceptual Evaluation of Voice - CAPE-V), as the reduction in the number of voice breaks and determining cepstral peak prominence will realize this goal. The investigators' preliminary data show that VTS induces improvements in voice quality in SD patients as measured by these markers.
- Demonstrate that repeated prolonged VTS produces long lasting improvements in SD voice quality that are retained for up to 3 months. SD patients will participate in an 8-week in-home VTS training program. After randomization to either a treatment or sham group (ineffective low frequency VTS), patients will start in low or high intensity training group (1 vs. 3 sessions/wk) and cross-over after 4 weeks. Showing that significant long-term voice improvements in the VTS treatment group as assessed by objective measures of voice/speech production (see aim 1) will persist over a period of 11 weeks will realize this goal.
- Demonstrate that the application of VTS induces acute desynchronization of cortical activity in SD, which would provide neurophysiological evidence on the assumed effectiveness of VTS. Verifying that VTS is associated with short-latency characteristic changes in somatosensory and motor cortical processing as measured by electroencephalography (EEG) and documenting that these changes indicate decreased alpha and beta-band activity in sensorimotor cortical areas will achieve this goal. The investigators' preliminary data show that VTS suppresses low frequency neural activity at the somatosensory and motor cortices in healthy and SD participants. Obtaining longitudinal EEG data during VTS training (aim 2), will allow the investigators to monitor long-term changes in cortical activation due to laryngeal VTS and to associate them with changes in voice quality.
Impact. This is the first systematic study on the effect of VTS on SD voice symptoms. The proposal aligns with PA-14-236 (Advancing Research in Voice Disorders) with its emphasis on understanding voice disorders and improving diagnosis and treatment. If successful, the work of the proposal would lay the scientific foundation for a clinical trial to examine the usefulness of the approach in a larger patient sample. It would document the sensorimotor cortical activation patterns associated with SD and the longitudinal changes in cortical responses to VTS. It would promote development of wearable, user-programmable medical devices that could apply VTS while monitoring its effect on voice production in real-time. Ultimately, VTS would enlarge the available therapeutic arsenal by either augmenting existing Botox therapy or becoming an alternative intervention option for patients who do not tolerate Botox injections.
- Conditions
- Spasmodic Dysphonia
- Being tested
- Laryngeal Vibration (Treatment), Laryngeal Vibration (Comparator)
- Keywords
- Dystonia, Spasmodic dysphonia, Laryngeal dystonia
- Medical subject headings
- Dysphonia, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Vibration (Treatment)Device
The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur.
Laryngeal Vibration (Comparator)Device
The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur.
| Study group | Role | What they receive |
|---|---|---|
| Low-High Treatment | Experimental | Participants in the low-high treatment group will receive Laryngeal Vibration (Treatment) at 100Hz frequency once a week for a duration of 4 weeks (low intensity). Then they will switch and receive laryngeal vibration at 100Hz frequency every second day of the week (high intensity) for a duration of 4 weeks. Receives: Device: Laryngeal Vibration (Treatment) |
| High-Low Treatment | Experimental | Participants in the high-low treatment group will receive Laryngeal Vibration (Treatment) at 100Hz frequency every second day of the week for a duration of 4 weeks (high intensity). Then they will switch and receive laryngeal vibration at 100Hz frequency once a week for a duration of 4 weeks (low intensity). Receives: Device: Laryngeal Vibration (Treatment) |
| Low-High Comparator | Active comparator | Participants in the low-high comparator group will receive Laryngeal Vibration (Comparator) at 5Hz frequency once a week for a duration of 4 weeks (low intensity). Then they will switch and receive laryngeal vibration at 5Hz frequency every second day of the week (high intensity) for a duration of 4 weeks. Receives: Device: Laryngeal Vibration (Comparator) |
| High-Low Comparator | Active comparator | Participants in the high-low comparator group will receive Laryngeal Vibration (Comparator) at 5Hz frequency every second day of the week for a duration of 4 weeks (high intensity). Then they will switch and receive laryngeal vibration at 5Hz frequency once a week for a duration of 4 weeks (low intensity). Receives: Device: Laryngeal Vibration (Comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice Assessment During First Visit
Smoothed Cepstral Peak Prominence (CPPS) is an indicator of voice quality. It is measured in decibels. CPPS was measured from the voice signals of each participant during each study visit, and relative CPPS was calculated before and after vibration was applied on the laryngeal muscles of the participants. An increase in CPPS value indicates an improvement in voice symptoms.
Measured: Testing performed in lab at Week 1
Final Voice Assessment
Smoothed Cepstral Peak Prominence (CPPS) which is an indicator of voice quality was measured in participants. CPPS was measured in participants during the first visit, and relative CPPS was calculated before and after vibration was applied on the laryngeal muscles of the participants.
Measured: Testing performed in lab at week 11
Secondary outcomes (2)
Measuring of Cortical Activity Using Electroencephalography (EEG) (Baseline)
Cortical activity before, during, and after the vibration will be recorded via a a 64-channel EEG system at a sampling frequency of 512 Hz.
Measured: Testing performed in lab at Week 1
Final Measuring of Cortical Activity Using Electroencephalography (EEG) to Measure Change From Baseline
Cortical activity before, during, and after the vibration will be recorded via a a 64-channel EEG system at a sampling frequency of 512 Hz.
Measured: Testing performed in lab at Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start2 Apr 2019
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spasmodic DysphoniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Juergen Konczak, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746509
- Sponsor's protocol ID
- KIN-2022-30628-2
- Other IDs
- R01DC016315
- Acronym
- SD-VTS
- Status last verified
- Apr 2025
- First submitted
- 14 Nov 2018
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khosravani S, Mahnan A, Yeh IL, Aman JE, Watson PJ, Zhang Y, Goding G, Konczak J. Laryngeal vibration as a non-invasive neuromodulation therapy for spasmodic dysphonia. Sci Rep. 2019 Nov 29;9(1):17955. doi: 10.1038/s41598-019-54396-4.
PubMed 31784618Konczak J, Bhaskaran D, Elangovan N, Oh J, Goding GS, Watson PJ. Effects of an 11-week vibro-tactile stimulation treatment on voice symptoms in laryngeal dystonia. Front Neurol. 2024 May 30;15:1403050. doi: 10.3389/fneur.2024.1403050. eCollection 2024.
PubMed 38872829
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Vibration as a Non-invasive Treatment for Spasmodic Dysphonia
- ClinicalTrials.gov ID
- NCT03746509
- Acronym / sponsor ID
- SD-VTS / KIN-2022-30628-2
- Conditions
- Spasmodic Dysphonia
- Keywords
- Dystonia, Spasmodic dysphonia, Laryngeal dystonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Posted 15 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of people with spasmodic dysphonia (SD). This research addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with limited treatment options. A successful completion of the proposed work will be an important step in advancing laryngeal VTS as a therapeutic intervention for improving the voice symptoms in SD. Specifically, the scientific yield by achieving the specific aims is threefold: First, it will elucidate the unknown neurophysiological mechanism behind laryngeal VTS by documenting the neural changes associated with VTS. Second, it will establish that VTS can improve voice quality in SD. Third, by documenting that laryngeal VTS yields long-term benefits on voice quality in SD patients, it would provide a solid basis for a clinical trial that needs to address open questions on optimal dosage and duration of VTS-based voice therapy, the magnitude of the therapeutic effect across adductor and abductor SD and its long term efficacy.
Detailed description
Spasmodic dysphonia (SD) is a rare voice disorder that develops spontaneously during midlife. Patients with SD typically have a strained or choked speech and report that is takes an exhausting effort to speak. The involuntary spasms of the laryngeal musculature that give rise to these symptoms almost always occur during speech. Progression is gradual in the first year and then becomes chronic for life. The cause of spasmodic dysphonia is unknown, but SD is considered to be a form of task-specific focal dystonia (FD). More women than men are affected. Current therapeutic options are limited. SD does not respond to behavioral speech therapy. It is treated primarily with Botulinum toxin injections (Botox), which provides temporary symptom relief to some, but is not well tolerated by all SD patients. At present, there is no cure for SD.
There is convergent evidence that FD is associated with kinaesthetic deficits that are also manifest in non-dystonic musculature indicating that while the motor symptoms of dystonia are focal, the associated somatosensory deficit is general. Recent work from our group (NIH 1R21DC011841) confirmed upper limb proprioceptive deficits in SD demonstrating that an underlying somatosensory deficit is also a feature of SD. In our assessment this finding opens an avenue for a missing behavioral treatment for SD. Specifically, the investigators suggest that vibro-tactile stimulation (VTS) could be the suitable tool, given that it is known to alter afferent signals from the vibrated mechanoreceptors in muscles and skin. The approach seeks to show that VTS represents a non-invasive form of neuromodulation that induces measurable improvements in the speech of SD patients. Given that SD, like other FDs, is associated with abnormally increased cortical excitation and heightened levels of neuronal synchronization, the investigators put forward that VTS can reduce sensorimotor cortical excitation in SD by desynchronizing motor cortical neuron activity as has been shown in cervical dystonia. Technically, newly available light-weight, wearable low-voltage vibrators offer, for the first time, the possibility to apply laryngeal VTS outside a controlled laboratory environment, which would be imperative for the technology to be clinically useful. In general, one needs to demonstrate that a) VTS induces measurable improvements in voice quality, b) that it induces measurable changes in somatosensory and motor cortical activation that would provide insight into the underlying neural mechanism of its potential effectiveness. Thus, the proposal has the following specific aims:
- Demonstrate that a one-time, prolonged application of VTS produces acute improvements in SD voice quality that are retained up to 60 minutes past cessation of VTS. A pre- and post-training comparison showing significant voice improvements in the SD group as measured by self-report (Effort Scale), clinical assessment (Consensus Auditory-Perceptual Evaluation of Voice - CAPE-V), as the reduction in the number of voice breaks and determining cepstral peak prominence will realize this goal. The investigators' preliminary data show that VTS induces improvements in voice quality in SD patients as measured by these markers.
- Demonstrate that repeated prolonged VTS produces long lasting improvements in SD voice quality that are retained for up to 3 months. SD patients will participate in an 8-week in-home VTS training program. After randomization to either a treatment or sham group (ineffective low frequency VTS), patients will start in low or high intensity training group (1 vs. 3 sessions/wk) and cross-over after 4 weeks. Showing that significant long-term voice improvements in the VTS treatment group as assessed by objective measures of voice/speech production (see aim 1) will persist over a period of 11 weeks will realize this goal.
- Demonstrate that the application of VTS induces acute desynchronization of cortical activity in SD, which would provide neurophysiological evidence on the assumed effectiveness of VTS. Verifying that VTS is associated with short-latency characteristic changes in somatosensory and motor cortical processing as measured by electroencephalography (EEG) and documenting that these changes indicate decreased alpha and beta-band activity in sensorimotor cortical areas will achieve this goal. The investigators' preliminary data show that VTS suppresses low frequency neural activity at the somatosensory and motor cortices in healthy and SD participants. Obtaining longitudinal EEG data during VTS training (aim 2), will allow the investigators to monitor long-term changes in cortical activation due to laryngeal VTS and to associate them with changes in voice quality.
Impact. This is the first systematic study on the effect of VTS on SD voice symptoms. The proposal aligns with PA-14-236 (Advancing Research in Voice Disorders) with its emphasis on understanding voice disorders and improving diagnosis and treatment. If successful, the work of the proposal would lay the scientific foundation for a clinical trial to examine the usefulness of the approach in a larger patient sample. It would document the sensorimotor cortical activation patterns associated with SD and the longitudinal changes in cortical responses to VTS. It would promote development of wearable, user-programmable medical devices that could apply VTS while monitoring its effect on voice production in real-time. Ultimately, VTS would enlarge the available therapeutic arsenal by either augmenting existing Botox therapy or becoming an alternative intervention option for patients who do not tolerate Botox injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-High Treatment | Experimental | Device: Laryngeal Vibration (Treatment)Participants in the low-high treatment group will receive Laryngeal Vibration (Treatment) at 100Hz frequency once a week for a duration of 4 weeks (low intensity). Then they will switch and receive laryngeal vibration at 100Hz frequency every second day of the week (high intensity) for a duration of 4 weeks. |
| High-Low Treatment | Experimental | Device: Laryngeal Vibration (Treatment)Participants in the high-low treatment group will receive Laryngeal Vibration (Treatment) at 100Hz frequency every second day of the week for a duration of 4 weeks (high intensity). Then they will switch and receive laryngeal vibration at 100Hz frequency once a week for a duration of 4 weeks (low intensity). |
| Low-High Comparator | Active comparator | Device: Laryngeal Vibration (Comparator)Participants in the low-high comparator group will receive Laryngeal Vibration (Comparator) at 5Hz frequency once a week for a duration of 4 weeks (low intensity). Then they will switch and receive laryngeal vibration at 5Hz frequency every second day of the week (high intensity) for a duration of 4 weeks. |
| High-Low Comparator | Active comparator | Device: Laryngeal Vibration (Comparator)Participants in the high-low comparator group will receive Laryngeal Vibration (Comparator) at 5Hz frequency every second day of the week for a duration of 4 weeks (high intensity). Then they will switch and receive laryngeal vibration at 5Hz frequency once a week for a duration of 4 weeks (low intensity). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of adductor SD for a minimum of 6 months with documented symptom relief after botox injection
Key exclusion criteria (2 listed)
- abductor SD
- patients with other voice disorders such as muscle tension dysphonia that share some of the symptomology with SD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngeal Vibration (Treatment)The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur. | Device | High-Low Treatment, Low-High Treatment |
| Laryngeal Vibration (Comparator)The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur. | Device | High-Low Comparator, Low-High Comparator |
Primary outcome
Voice Assessment During First Visit
Time frame: Testing performed in lab at Week 1
Smoothed Cepstral Peak Prominence (CPPS) is an indicator of voice quality. It is measured in decibels. CPPS was measured from the voice signals of each participant during each study visit, and relative CPPS was calculated before and after vibration was applied on the laryngeal muscles of the participants. An increase in CPPS value indicates an improvement in voice symptoms.
Final Voice Assessment
Time frame: Testing performed in lab at week 11
Smoothed Cepstral Peak Prominence (CPPS) which is an indicator of voice quality was measured in participants. CPPS was measured in participants during the first visit, and relative CPPS was calculated before and after vibration was applied on the laryngeal muscles of the participants.
2 secondary outcomes
Measuring of Cortical Activity Using Electroencephalography (EEG) (Baseline)
Time frame: Testing performed in lab at Week 1
Final Measuring of Cortical Activity Using Electroencephalography (EEG) to Measure Change From Baseline
Time frame: Testing performed in lab at Week 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31784618Khosravani S, Mahnan A, Yeh IL, Aman JE, Watson PJ, Zhang Y, Goding G, Konczak J. Laryngeal vibration as a non-invasive neuromodulation therapy for spasmodic dysphonia. Sci Rep. 2019 Nov 29;9(1):17955. doi: 10.1038/s41598-019-54396-4.
- Results publication: PubMed 38872829Konczak J, Bhaskaran D, Elangovan N, Oh J, Goding GS, Watson PJ. Effects of an 11-week vibro-tactile stimulation treatment on voice symptoms in laryngeal dystonia. Front Neurol. 2024 May 30;15:1403050. doi: 10.3389/fneur.2024.1403050. eCollection 2024.
- Invesitgator laboratory website summarizing study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Juergen Konczak, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal Vibration (Treatment) and Laryngeal Vibration (Comparator) in people with Spasmodic Dysphonia, run by University of Minnesota 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 1 inclusion and 2 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 4 May 2025. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Voice Assessment During First Visit (time frame: Testing performed in lab at Week 1). The study lists 2 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 NCT03746509, which also lists 2 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 4 May 2025.