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Laryngeal 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
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 12, 2022
Last Updated
June 29, 2023
Sponsor
University of Minnesota
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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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