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rTMS in Spasmodic Dysphonia

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ClinicalTrials.gov Identifier: NCT02957942
Recruitment Status : Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Spasmodic Dysphonia Laryngeal Dystonia Device: 1Hz repetitive transcranial magnetic stimulation (rTMS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Repetitive Transcranial Magnetic Stimulation in Spasmodic Dysphonia
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Spasmodic Dysphonia
1Hz repetitive transcranial magnetic stimulation (rTMS)
Device: 1Hz repetitive transcranial magnetic stimulation (rTMS)
1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
Active Comparator: Healthy control
Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS)
Device: 1Hz repetitive transcranial magnetic stimulation (rTMS)
1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)



Primary Outcome Measures :
  1. Adverse response to rTMS [ Time Frame: Baseline treatment ]
    Check sheet of possible adverse events.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary inclusion for spasmodic dysphonia:

    1. Diagnosis of adductor spasmodic dysphonia
    2. Symptoms at worst severity if receiving regular botulinum injections
  • Primary inclusion for healthy participants (controls):

    1. Absence of vocal fold pathology

Exclusion Criteria:

  • Primary exclusion for participants with spasmodic dysphonia:

    1. Other forms of dystonia
    2. Vocal fold pathology or paralysis
    3. Diagnosis of voice tremor
    4. Laryngeal surgery
    5. Laryngeal cancer or neurological condition other than dystonia
    6. Contraindication to TMS
    7. Medications with effect on central nervous system
    8. Inability to complete tasks associated with study
    9. Adult lacking ability to consent
  • Primary exclusion for healthy participants (controls):

    1. Any health condition or disability that would interfere with participation
    2. Contraindications to TMS
    3. Medications with effect on central nervous system
    4. Adult lacking ability to consent

TMS contraindications:

  • The only absolute contraindication to TMS/rTMS is the presence of metallic hardware in close contact to the discharging coil (such as cochlear implants, deep brain stimulator, or medication pumps). In such instances there is a risk of inducing malfunctioning of the implanted devices.
  • Conditions classified as of increased or uncertain risk are listed below (Rossi et al., 2009; Rossini et al., 2015). Persons under those circumstances will be excluded from the study.

    1. Pregnancy
    2. Bipolar disorder
    3. Epilepsy or history of seizure episodes in the past two years
    4. Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
    5. Use of medications that potentially lower seizure threshold
    6. Severe or recent heart disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957942


Locations
United States, Minnesota
Noninvasive Neuromodulation Laboratory
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Mo Chen, PhD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Teresa J Kimberley, PhD, PT Massachusetts General Hospital

Publications:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02957942     History of Changes
Other Study ID Numbers: 1609M94001
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Repetitive transcranial magnetic stimulation (rTMS)
Spasmodic dysphonia
Dystonia

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dysphonia
Hoarseness
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiration Disorders
Signs and Symptoms, Respiratory