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Behavioural Intervention

Vibro-tactile Stimulation for Spasmodic Dysphonia

Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I have had spasmodic dysphonia for over 6 months and Botox has helped my symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Perceived voice effort
Secondary outcome measures
The duration of voice break
The number of voice breaks

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
1,381 Previous Clinical Trials
1,588,935 Total Patients Enrolled
2 Trials studying Spasmodic Dysphonia
62 Patients Enrolled for Spasmodic Dysphonia
Juergen KonczakPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current availability of enrollment openings for this investigation?

"Clinicaltrials.gov states that this trial is presently recruiting patients, first posted on September 20th of 2023 and updated most recently on October 29th of the same year."

Answered by AI

Does this clinical trial permit those aged fifty and above to enroll?

"This clinical trial is open to applicants from 18 to 75 years of age. There are 6 studies for those who are under the legal age and 48 trials available to individuals over 65."

Answered by AI

What criteria must be met for someone to qualify as a participant in this research?

"Patients who suffer from spasmodic dysphonia and are between 18 to 75 years old may be eligible for this trial. We anticipate recruiting approximately 40 participants."

Answered by AI

How many participants is the trial open to recruiting?

"Affirmative. According to clinicaltrials.gov, enrollment for this medical trial is still open and the last update was on October 29th 2023. Forty participants from one site are sought after for this experiment."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~13 spots leftby Sep 2024