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Behavioural Intervention
Vibro-tactile Stimulation for Spasmodic Dysphonia
Phase 1 & 2
Waitlist Available
Led By Juergen Konczak
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of spasmodic dysphonia (laryngeal dystonia) for a minimum of 6 months with documented symptom relief after Botox injection.
Be older than 18 years old
Must not have
Identifies with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia, 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 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a non-invasive form of neuromodulation to help improve speech in people with a rare voice disorder. It could be a big step in advancing treatment options for this condition.
Who is the study for?
This trial is for individuals who have been diagnosed with spasmodic dysphonia, a rare voice disorder, for at least 6 months and have seen symptom relief after Botox injections. Participants must not be regularly taking benzodiazepines or have neurological conditions that affect speech.
What is being tested?
The study tests the use of vibro-tactile stimulation (VTS) as a home-based treatment to improve speech in people with spasmodic dysphonia. It aims to establish VTS as an alternative therapy by demonstrating its usability and effectiveness.
What are the potential side effects?
Since this trial involves non-invasive neuromodulation through VTS, specific side effects are not detailed but may include discomfort or skin irritation where the device is applied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had spasmodic dysphonia for over 6 months and Botox has helped my symptoms.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition that affects my ability to speak due to a neurological or musculoskeletal issue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Perceived voice effort
Secondary study objectives
The duration of voice break
The number of voice breaks
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Will use the device, single group
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,423 Previous Clinical Trials
1,619,745 Total Patients Enrolled
2 Trials studying Spasmodic Dysphonia
62 Patients Enrolled for Spasmodic Dysphonia
Juergen KonczakPrincipal InvestigatorUniversity of Minnesota
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