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Clinical Trials/NCT02957942
NCT02957942
Completed
Not Applicable

Repetitive Transcranial Magnetic Stimulation in Spasmodic Dysphonia

University of Minnesota1 site in 1 country20 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spasmodic Dysphonia
Sponsor
University of Minnesota
Enrollment
20
Locations
1
Primary Endpoint
Change in Duration of Cortical Silent Period (CSP)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Focal dystonia is a neurological movement disorder characterized by excessive involuntary muscle contractions of any body part. Spasmodic dysphonia (SD) is a type of focal dystonia characterized by excessive contraction of intrinsic muscles in the larynx, leading to difficulty in speaking and affecting effective communication. The cause of SD is unknown and there are no treatments that produce long-term benefits. Previous studies have suggested that SD and other focal dystonias are associated with decreased inhibition in sensorimotor areas in the brain. However, no studies have investigated the effects of modulating excitability of the laryngeal motor cortex in healthy individuals or SD. The goal of this pilot project is to determine if brain excitability of the laryngeal motor cortex can be changed with low-frequency inhibitory repetitive transcranial magnetic stimulation (rTMS) in individuals with SD and healthy controls. Considering that rTMS at low frequencies (≤1 Hz) produces lasting inhibition in the brain, and that SD is associated with decreased cortical inhibition, the purpose of this pilot study is to determine safety, feasibility and response to 1Hz rTMS to the laryngeal motor cortex in individuals with SD and healthy people. The results will help understand changes associated with the disorder, as well as contribute to the development of future clinical interventions for SD.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
December 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Primary inclusion for spasmodic dysphonia:
  • Diagnosis of adductor spasmodic dysphonia
  • Symptoms at worst severity if receiving regular botulinum injections
  • Primary inclusion for healthy participants (controls):
  • Absence of vocal fold pathology

Exclusion Criteria

  • Primary exclusion for participants with spasmodic dysphonia:
  • Other forms of dystonia
  • Vocal fold pathology or paralysis
  • Diagnosis of voice tremor
  • Laryngeal surgery
  • Laryngeal cancer or neurological condition other than dystonia
  • Contraindication to TMS
  • Medications with effect on central nervous system
  • Inability to complete tasks associated with study
  • Adult lacking ability to consent

Outcomes

Primary Outcomes

Change in Duration of Cortical Silent Period (CSP)

Time Frame: baseline and 2.5 hours

The change from baseline in CSP duration will be reported. The CSP is an interruption of voluntary muscle contraction after single pulse transcranial stimulation. The duration of the period of silent muscle activity will be measured to test the effects of rTMS intervention. There is no known clinical relevance for this outcome measure.

Adverse Response to rTMS

Time Frame: 2.5 hours

Count of participants who experience and adverse response to rTMS treatment.

Secondary Outcomes

  • Change in Cepstral Peak Prominence Smoothed (CPPS)(baseline and 2.5 hours)
  • Change in Number of Voice Breaks(baseline and 2.5 hours)
  • Change in Voice Quality (Overall Severity) With the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)(baseline and 2.5 hours)

Study Sites (1)

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