- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746509
Laryngeal Vibration for Spasmodic Dysphonia (SD-VTS)
Laryngeal Vibration as a Non-invasive Treatment for Spasmodic Dysphonia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosis of adductor SD for a minimum of 6 months with documented symptom relief after botox injection
Exclusion Criteria:
- abductor SD
- patients with other voice disorders such as muscle tension dysphonia that share some of the symptomology with SD
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Experimental: 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).
|
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.
|
Active Comparator: 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.
|
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.
|
Active Comparator: 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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Testing performed in lab at Week 1
|
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.
|
Testing performed in lab at week 11
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring of Cortical Activity Using Electroencephalography (EEG) (Baseline)
Time Frame: Testing performed in lab at Week 1
|
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
Time Frame: Testing performed in lab at Week 11
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juergen Konczak, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KIN-2022-30628-2
- R01DC016315 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spasmodic Dysphonia
-
University of California, San FranciscoRecruitingSpasmodic Dysphonia | Adductor Spasmodic Dysphonia | Voice DisordersUnited States
-
Kumamoto UniversityKyoto University; Hokkaido University Hospital; Yokohama City University HospitalCompletedAdductor Spasmodic DysphoniaJapan
-
University of Wisconsin, MadisonCompleted
-
University of California, San FranciscoNational Spasmodic Dysphonia AssociationCompletedSpasmodic Dysphonia | Adductor Spasmodic Dysphonia | Voice DisordersUnited States
-
Lawson Health Research InstituteUnknownAdductor Spasmodic DysphoniaCanada
-
University of MinnesotaNot yet recruitingAdductor Spasmodic Dysphonia | Laryngeal Dystonia | Abductor Spastic DysphoniaUnited States
-
National Institute of Neurological Disorders and...Completed
-
Eastern Virginia Medical SchoolRecruitingDysphonia | Laryngeal Dystonia | Dysphonia, SpasticUnited States
-
University of British ColumbiaNot yet recruiting
Clinical Trials on Laryngeal Vibration (Treatment)
-
University of ThessalyThomas Besios; Georgios Paras; Konstantinos ChandoliasCompletedCerebral Palsy | Spastic Hemiplegic Cerebral PalsyGreece
-
Chinese University of Hong KongV-Health LimitedRecruitingOsteoporosis | Vibration Therapy | WheelchairHong Kong
-
Riphah International UniversityCompletedStroke, SubacutePakistan
-
Chinese University of Hong KongRecruiting
-
Chinese University of Hong KongCompleted
-
Chinese University of Hong KongCompleted
-
Cairo UniversityCompleted
-
Chinese University of Hong KongAbbottRecruitingSarcopenia | Musculoskeletal Abnormalities | Connective Tissue Diseases in Old AgeHong Kong
-
Riphah International UniversityCompletedCerebral PalsyPakistan
-
Cairo UniversityCompleted