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Behavioural Intervention

Vibro-tactile Stimulation for Spasmodic Dysphonia

Phase 2
Waitlist Available
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of adductor or abductor LD for a minimum of 6 months.
18 years of age or older
Must not have
Regular intake of benzodiazepines
Neurological or musculoskeletal impairment affecting speech motor function including 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether vibro-tactile stimulation can help improve the speech of people with laryngeal dystonia (a movement disorder that affects the muscles of the larynx).

Who is the study for?
This trial is for adults over 18 with a confirmed diagnosis of adductor or abductor spasmodic dysphonia (a voice disorder) for at least 6 months. It's not suitable for those with cognitive issues, regular benzodiazepine users, pregnant individuals, non-English speakers, or people with certain neurological conditions affecting speech.
What is being tested?
The study tests whether vibro-tactile stimulation (VTS), a non-invasive treatment that uses vibrations on the throat area, can improve speech in patients suffering from laryngeal dystonia or spasmodic dysphonia.
What are the potential side effects?
Since VTS is non-invasive and doesn't involve drugs, significant side effects are not expected. However, participants may experience discomfort or mild irritation where the device touches the skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with laryngeal dystonia for at least 6 months.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I regularly take benzodiazepines.
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I have a condition affecting my ability to speak due to muscle or nerve issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in perceived speech effort (PSE)
Change in smoothed cepstral peak prominence (CPPS)
Change in speech quality vector (SQV) (%)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Low dose / speech activated VTSExperimental Treatment1 Intervention
Low dose refers to receiving VTS 5 times/week for 20 minutes each; VTS during connected speech
Group II: Low dose / continuous VTSExperimental Treatment1 Intervention
Low dose refers to receiving VTS 5 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech
Group III: High dose / speech activated VTSExperimental Treatment1 Intervention
High dose refers to receiving VTS 7 times/week for 20 minutes each; VTS during connected speech
Group IV: High dose / continuous VTSExperimental Treatment1 Intervention
High dose refers to receiving VTS 7 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,436 Previous Clinical Trials
1,621,623 Total Patients Enrolled
3 Trials studying Spasmodic Dysphonia
102 Patients Enrolled for Spasmodic Dysphonia

Media Library

Vibro-tactile stimulation (VTS) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05467228 — Phase 2
Spasmodic Dysphonia Research Study Groups: High dose / speech activated VTS, Low dose / continuous VTS, Low dose / speech activated VTS, High dose / continuous VTS
Spasmodic Dysphonia Clinical Trial 2023: Vibro-tactile stimulation (VTS) Highlights & Side Effects. Trial Name: NCT05467228 — Phase 2
Vibro-tactile stimulation (VTS) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05467228 — Phase 2
~40 spots leftby Aug 2026
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