- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05467228
Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
June 29, 2023 updated by: University of Minnesota
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 patients with laryngeal dystonia (LD) - also called spasmodic dysphonia (SD).
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jürgen Konczak, PhD
- Phone Number: 612-624-4370
- Email: jkonczak@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
Contact:
- Jürgen Konczak, PhD
- Phone Number: 612-624-4370
- Email: jkonczak@umn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 years of age or older
- Confirmed diagnosis of adductor or abductor LD for a minimum of 6 months.
Exclusion Criteria:
- Regular intake of benzodiazepines
- Cognitive impairment: score < 27 on the Mini-mental State Examination (MMSE).
- Identify with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia other than LD, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis.
- Non-English speaker. We will not enroll people who cannot speak English, because the voice assessment procedures (Test sentences, CAPE_V clinical rating) have only been validated for English speakers at this point.
- Pregnant people. We will not enroll pregnant people as the device used in this study is investigational.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose / continuous VTS
Low dose refers to receiving VTS 5 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech
|
To apply vibro-tactile stimulation, participants will use a wearable device.
It contains two vibratory motors (Precision MicrodrivesTM, Model 307 - 100) that are low-voltage (~1V), non-invasive and will be located approximately above the lateral portions of the thyroid cartilage.
For this protocol, they vibrate at frequencies between 40 - 100 Hz (i.e., 100 times per second
|
Experimental: Low dose / speech activated VTS
Low dose refers to receiving VTS 5 times/week for 20 minutes each; VTS during connected speech
|
To apply vibro-tactile stimulation, participants will use a wearable device.
It contains two vibratory motors (Precision MicrodrivesTM, Model 307 - 100) that are low-voltage (~1V), non-invasive and will be located approximately above the lateral portions of the thyroid cartilage.
For this protocol, they vibrate at frequencies between 40 - 100 Hz (i.e., 100 times per second
|
Experimental: High dose / continuous VTS
High dose refers to receiving VTS 7 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech
|
To apply vibro-tactile stimulation, participants will use a wearable device.
It contains two vibratory motors (Precision MicrodrivesTM, Model 307 - 100) that are low-voltage (~1V), non-invasive and will be located approximately above the lateral portions of the thyroid cartilage.
For this protocol, they vibrate at frequencies between 40 - 100 Hz (i.e., 100 times per second
|
Experimental: High dose / speech activated VTS
High dose refers to receiving VTS 7 times/week for 20 minutes each; VTS during connected speech
|
To apply vibro-tactile stimulation, participants will use a wearable device.
It contains two vibratory motors (Precision MicrodrivesTM, Model 307 - 100) that are low-voltage (~1V), non-invasive and will be located approximately above the lateral portions of the thyroid cartilage.
For this protocol, they vibrate at frequencies between 40 - 100 Hz (i.e., 100 times per second
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in perceived speech effort (PSE)
Time Frame: 24 months
|
Speaker will assess effort themselves and assign an score (range: 0-10 with a score of '10' indicating most severe effort)
|
24 months
|
Change in smoothed cepstral peak prominence (CPPS)
Time Frame: 24 months
|
CPPS provides a measure of the strength of the fundamental frequency within background aperiodicity (physical unit is dB)
|
24 months
|
Change in speech quality vector (SQV) (%)
Time Frame: 24 months
|
A derived measure designed to understand if a participant's voice symptom improvement occurs across objective (CPPS) and subjective measures of speech (PSE).
It is based on the relative change between two time points
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
July 12, 2022
First Submitted That Met QC Criteria
July 18, 2022
First Posted (Actual)
July 20, 2022
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 29, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Otorhinolaryngologic Diseases
- Movement Disorders
- Neuromuscular Manifestations
- Dyskinesias
- Signs and Symptoms, Respiratory
- Muscle Hypertonia
- Laryngeal Diseases
- Voice Disorders
- Dystonia
- Dystonic Disorders
- Muscle Spasticity
- Dysphonia
- Hoarseness
Other Study ID Numbers
- KIN-2022-30628
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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.
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