rTMS in Spasmodic Dysphonia
Repetitive Transcranial Magnetic Stimulation in Spasmodic Dysphonia
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2016
CompletedFirst Posted
Study publicly available on registry
November 8, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedResults Posted
Study results publicly available
October 1, 2020
CompletedOctober 1, 2020
September 1, 2020
1.9 years
October 26, 2016
September 2, 2020
September 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse Response to rTMS
Count of participants who experience and adverse response to rTMS treatment.
2.5 hours
Change in Duration of Cortical Silent Period (CSP)
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.
baseline and 2.5 hours
Secondary Outcomes (3)
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
Change in Cepstral Peak Prominence Smoothed (CPPS)
baseline and 2.5 hours
Study Arms (2)
Spasmodic Dysphonia
EXPERIMENTAL1Hz repetitive transcranial magnetic stimulation (rTMS)
Healthy control
ACTIVE COMPARATORHealthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS)
Interventions
1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
Eligibility Criteria
You may qualify if:
- Diagnosis of adductor spasmodic dysphonia
- Symptoms at worst severity if receiving regular botulinum injections
- Absence of vocal fold pathology
You may not qualify if:
- 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
- Any health condition or disability that would interfere with participation
- Contraindications to TMS
- Medications with effect on central nervous system
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Noninvasive Neuromodulation Laboratory
Minneapolis, Minnesota, 55455, United States
Related Publications (6)
Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
PMID: 19833552BACKGROUNDRossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.
PMID: 25797650BACKGROUNDSummers RL, Chen M, Kimberley TJ. Corticospinal excitability measurements using transcranial magnetic stimulation are valid with intramuscular electromyography. PLoS One. 2017 Feb 23;12(2):e0172152. doi: 10.1371/journal.pone.0172152. eCollection 2017.
PMID: 28231250BACKGROUNDKimberley TJ, Schmidt RL, Chen M, Dykstra DD, Buetefisch CM. Mixed effectiveness of rTMS and retraining in the treatment of focal hand dystonia. Front Hum Neurosci. 2015 Jul 9;9:385. doi: 10.3389/fnhum.2015.00385. eCollection 2015.
PMID: 26217209BACKGROUNDChen M, Summers RL, Goding GS, Samargia S, Ludlow CL, Prudente CN, Kimberley TJ. Evaluation of the Cortical Silent Period of the Laryngeal Motor Cortex in Healthy Individuals. Front Neurosci. 2017 Mar 7;11:88. doi: 10.3389/fnins.2017.00088. eCollection 2017.
PMID: 28326007BACKGROUNDPrudente CN, Chen M, Stipancic KL, Marks KL, Samargia-Grivette S, Goding GS, Green JR, Kimberley TJ. Effects of low-frequency repetitive transcranial magnetic stimulation in adductor laryngeal dystonia: a safety, feasibility, and pilot study. Exp Brain Res. 2022 Feb;240(2):561-574. doi: 10.1007/s00221-021-06277-4. Epub 2021 Dec 2.
PMID: 34859288DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mo Chen
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Mo Chen, PhD
University of Minnesota
- PRINCIPAL INVESTIGATOR
Teresa J Kimberley, PhD, PT
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2016
First Posted
November 8, 2016
Study Start
January 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
October 1, 2020
Results First Posted
October 1, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share