Clinical Trial: rTMS in Spasmodic Dysphonia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Repetitive Transcranial Magnetic Stimulation in Spasmodic Dysphonia

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.

Detailed Summary:
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome:

  • Adverse response to rTMS [ Time Frame: Baseline treatment ]
    Check sheet of possible adverse events.
  • Change in duration of cortical silent period (CSP) [ Time Frame: Baseline after treatment ]
    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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in number of voice breaks [ Time Frame: Baseline after treatment ]
    Changes from baseline in the number of voice breaks during speech will be reported. Voice breaks will be measured by asking subjects to repeat 10 sentences. The frequency of voice breaks in the recorded 10 sentences will be counted.
  • Change in voice quality with the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) [ Time Frame: Baseline after treatment ]
    Changes from baseline in voice disability will be reported. Voice disability will be assessed by voice experts with the CAPE-V. The CAPE-V is a scale for rating voice loudness, pitch, strain, breathiness, roughness, overall severity and other aspects.


Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: October 26, 2016
Date Started: January 2017
Date Completion: December 2017
Last Updated: April 26, 2017
Last Verified: April 2017