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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC016315 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| 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. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Testing performed in lab at week 11 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Testing performed in lab at Week 1 |
| Final Measuring of Cortical Activity Using Electroencephalography (EEG) to Measure Change From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juergen Konczak, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31784618 | Background | 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. | |
| 38872829 | Result | Konczak 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. |
| Label | URL |
|---|---|
| Invesitgator laboratory website summarizing study results | View source |
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Participants were recruited from Fairview Voice Clinic at the University of Minnesota and through e-mail advertisements sent by the National Spasmodic Dysphonia Association as well as social media platforms.
Recruitment began in the Fall of 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low-High 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. 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. |
| FG001 | High-Low 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). 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. |
| FG002 | Low-High 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. 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. |
| FG003 | High-Low 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). 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-High 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | decibel | Testing performed in lab at Week 1 |
|
11 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-High 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. 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. |
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Dosage was limited to apply vibro-tactile stimulation for one day or days per week for 20 min/day. It is unclear how a more frequent or longer application of the stimulation will affect voice outcome in people with laryngeal dystonia.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juergen Konczak | University of Minnesota | 612-624-4370 | jkonczak@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2021 | Nov 28, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 31, 2021 | Nov 28, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055154 | Dysphonia |
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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. |
|
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. |
| Testing performed in lab at Week 11 |
| BG001 | High-Low 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). 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. |
| BG002 | Low-High 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. 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. |
| BG003 | High-Low 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). 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | High-Low 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). 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. |
| OG002 | Low-High 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. 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. |
| OG003 | High-Low 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). 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. |
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| Primary | 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. | Posted | Median | Inter-Quartile Range | decibel | Testing performed in lab at week 11 |
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| Secondary | 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. | Not Posted | Testing performed in lab at Week 1 | Participants |
| Secondary | 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. | Not Posted | Testing performed in lab at Week 11 | Participants |
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | High-Low 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). 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Low-High 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. 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. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | High-Low 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). 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020820 | Dyskinesias |