Back to resultsLaryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
Primary Purpose
Adductor Spasmodic Dysphonia, Abductor Spastic Dysphonia, Laryngeal Dystonia
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
vibro-tactile stimulation (VTS)
Sponsored by
About this trial
This is an interventional treatment trial for Adductor Spasmodic Dysphonia focused on measuring Adductor Spasmodic Dysphonia, Abductor Spastic Dysphonia, Laryngeal Dystonia, Vibtro-tactile stimulation
Eligibility Criteria
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.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Low dose / continuous VTS
Low dose / speech activated VTS
High dose / continuous VTS
High dose / speech activated VTS
Arm Description
Low dose refers to receiving VTS 5 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech
Low dose refers to receiving VTS 5 times/week for 20 minutes each; VTS during connected speech
High dose refers to receiving VTS 7 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech
High dose refers to receiving VTS 7 times/week for 20 minutes each; VTS during connected speech
Outcomes
Primary Outcome Measures
Change in perceived speech effort (PSE)
Speaker will assess effort themselves and assign an score (range: 0-10 with a score of '10' indicating most severe effort)
Change in smoothed cepstral peak prominence (CPPS)
CPPS provides a measure of the strength of the fundamental frequency within background aperiodicity (physical unit is dB)
Change in speech quality vector (SQV) (%)
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05467228
Brief Title
Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
Official Title
Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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 patients with laryngeal dystonia (LD) - also called spasmodic dysphonia (SD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adductor Spasmodic Dysphonia, Abductor Spastic Dysphonia, Laryngeal Dystonia
Keywords
Adductor Spasmodic Dysphonia, Abductor Spastic Dysphonia, Laryngeal Dystonia, Vibtro-tactile stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low dose / continuous VTS
Arm Type
Experimental
Arm Description
Low dose refers to receiving VTS 5 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech
Arm Title
Low dose / speech activated VTS
Arm Type
Experimental
Arm Description
Low dose refers to receiving VTS 5 times/week for 20 minutes each; VTS during connected speech
Arm Title
High dose / continuous VTS
Arm Type
Experimental
Arm Description
High dose refers to receiving VTS 7 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech
Arm Title
High dose / speech activated VTS
Arm Type
Experimental
Arm Description
High dose refers to receiving VTS 7 times/week for 20 minutes each; VTS during connected speech
Intervention Type
Device
Intervention Name(s)
vibro-tactile stimulation (VTS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in perceived speech effort (PSE)
Description
Speaker will assess effort themselves and assign an score (range: 0-10 with a score of '10' indicating most severe effort)
Time Frame
24 months
Title
Change in smoothed cepstral peak prominence (CPPS)
Description
CPPS provides a measure of the strength of the fundamental frequency within background aperiodicity (physical unit is dB)
Time Frame
24 months
Title
Change in speech quality vector (SQV) (%)
Description
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
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jürgen Konczak, PhD
Phone
612-624-4370
Email
jkonczak@umn.edu
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürgen Konczak, PhD
Phone
612-624-4370
Email
jkonczak@umn.edu
12. IPD Sharing Statement
Learn more about this trial
Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
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