Cortical Silent Period in Laryngeal Dystonia

NCT05580302 | Unknown DMC

• 1 other identifier: 003-08/22-03/0003
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the cortical silent period (cSP) in cricothyroid muscle (CT) in laryngeal dystonia and control healthy subjects. The study will provide norms related to latency and amplitude of motor evoked potentials (MEPs) and duration of cSP in CT muscle in laryngeal dystonia and control healthy subjects. Findings may give a baseline in comparison to findings in laryngeal diseases and insight into maladaptive cortical control function during phonation in laryngeal diseases like laryngeal dystonia.

Conditions

Laryngeal Dystonia; Spasmodic Dysphonia

Keywords

laryngeal dystonia; cortical silent period; spasmodic dysphonia; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (3)

• Motor evoked potential (MEP) latency

  MEP latency is expressed in milliseconds

  MEP latency evaluated on the first day of the arrival on TMS experiment

• Motor evoked potential (MEP) amplitude

  MEP amplitude is expressed in microvolts

  MEP amplitude evaluated on the first day of the arrival on TMS experiment

• Duration of cortical silent period (cSP)

  cSP is expressed in milliseconds

  cSP duration evaluated on the first day of the arrival on TMS experiment

Study Arms (2)

Laryngeal Dystonia

The study will be performed on 10-15 (maximal 20) subjects with diagnosed laryngeal dystonia who meet the exclusion/ inclusion criteria. Inclusion criteria: adults (18-65 years old) who have confirmed diagnosis of laryngeal dystonia, no implanted metals in body (e.g. pacemaker, metal prosthesis in skull and oral cavity). Exclusion criteria: pregnancy, other neurological disorders, psychiatric disorders, epilepsy or history of previous epilepsy attack, using of brain affecting pharmaceuticals, traumatic, tumor, infectious, metabolic brain lesions, heart conditions (15 ). The composition of the group is represented is both gender, various age gap, and different height. Before the beginning of testing, all subjects with a confirmed diagnosis of laryngeal dystonia will be once again evaluated by a specialist otorhinolaryngologist at the University Hospital of Split. Medical documentation of the examination will be available for further analysis.

Other: Transcranial Magnetic Stimulation (TMS)

Healthy subjects

The study will be performed on 20 healthy volunteering subjects who meet the exclusion/ inclusion criteria. Inclusion criteria: healthy adults (18-65 years old), no implanted metals in body (e.g. pacemaker, metal prosthesis in the skull and oral cavity) Exclusion criteria: pregnancy, neurological disorders, psychiatric disorders, epilepsy or history of previous epilepsy attack, using of the brain affecting pharmaceuticals, traumatic, tumor, infectious, metabolic brain lesions, heart conditions. The composition of the group is represented is both gender, various age gap, and different height.

Other: Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS) OTHER

An anatomical T1 magnetic resonance image (MRI) with high resolution will be acquired on a separate day before the TMS experiment. The image will be imported into the neuronavigation system (Nexstim, Helsinki, Finland) to guide the localization of the primary motor cortex (M1) for laryngeal muscle representation. Prior to M1 mapping for laryngeal muscle representation, mapping of the representation for hand muscle representation will be performed. Hand region excitability (abductor pollicis brevis, APB) will be evaluated by using surface electrodes attached to the right-hand APB muscle. The cSP threshold is defined as the lowest TMS intensity that elicits a cSP in 5 out of 10 consecutive trials. Single-pulse cortical stimulations will be performed during the vocalization of sustained /i/ sound.

Healthy subjects; Laryngeal Dystonia

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inclusion Criteria: * adults (18-65 years old) with diagnosed laryngeal dystonia, no implanted metals in the body (e.g. pacemaker, metal prosthesis in the skull and oral cavity). Exclusion Criteria: * pregnancy, other neurological disorders, psychiatric disorders, epilepsy or history of previous epilepsy attack, use of brain-affecting pharmaceuticals, traumatic, tumor, infectious, metabolic brain lesions, heart conditions. The composition of the group is represented is both gender, various age gap, and different height.

You may qualify if:

• adults (18-65 years old), no implanted metals in the body (e.g. pacemaker, metal prosthesis in the skull and oral cavity).

You may not qualify if:

• pregnancy, other neurological disorders (except laryngeal dystonia in the laryngeal dystonia group), psychiatric disorders, epilepsy or history of previous epilepsy attack, using of brain-affecting pharmaceuticals, traumatic, tumor, infectious, metabolic brain lesions, heart conditions.
• The composition of the group is represented is both gender, various age gap, and different height.

Sponsors & Collaborators

• University of Split, School of Medicine: lead
• University Hospital of Split: collaborator

Study Sites (1)

University of Split School of Medicine

Split, 21000, Croatia

RECRUITING

Related Publications (8)

• Blitzer A, Brin MF, Stewart CF. Botulinum toxin management of spasmodic dysphonia (laryngeal dystonia): a 12-year experience in more than 900 patients. Laryngoscope. 2015 Aug;125(8):1751-7. doi: 10.1002/lary.25273. No abstract available.

  PMID: 26200329 BACKGROUND

• Pirio Richardson S, Wegele AR, Skipper B, Deligtisch A, Jinnah HA; Dystonia Coalition Investigators. Dystonia treatment: Patterns of medication use in an international cohort. Neurology. 2017 Feb 7;88(6):543-550. doi: 10.1212/WNL.0000000000003596. Epub 2017 Jan 11.

  PMID: 28077492 BACKGROUND

• Deletis V, Rogic M, Fernandez-Conejero I, Gabarros A, Jeroncic A. Neurophysiologic markers in laryngeal muscles indicate functional anatomy of laryngeal primary motor cortex and premotor cortex in the caudal opercular part of inferior frontal gyrus. Clin Neurophysiol. 2014 Sep;125(9):1912-22. doi: 10.1016/j.clinph.2014.01.023. Epub 2014 Feb 11.

  PMID: 24613682 BACKGROUND

• Chen 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: 28326007 BACKGROUND

• Chen M, Summers RLS, Prudente CN, Goding GS, Samargia-Grivette S, Ludlow CL, Kimberley TJ. Transcranial magnetic stimulation and functional magnet resonance imaging evaluation of adductor spasmodic dysphonia during phonation. Brain Stimul. 2020 May-Jun;13(3):908-915. doi: 10.1016/j.brs.2020.03.003. Epub 2020 Mar 13.

  PMID: 32289724 BACKGROUND

• Rossini 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: 25797650 BACKGROUND

• Simonyan K, Barkmeier-Kraemer J, Blitzer A, Hallett M, Houde JF, Jacobson Kimberley T, Ozelius LJ, Pitman MJ, Richardson RM, Sharma N, Tanner K; The NIH/NIDCD Workshop on Research Priorities in Spasmodic Dysphonia/Laryngeal Dystonia. Laryngeal Dystonia: Multidisciplinary Update on Terminology, Pathophysiology, and Research Priorities. Neurology. 2021 May 25;96(21):989-1001. doi: 10.1212/WNL.0000000000011922. Epub 2021 Apr 15.

  PMID: 33858994 BACKGROUND

• Rogic Vidakovic M, Schonwald MZ, Rotim K, Juric T, Vulevic Z, Tafra R, Banozic A, Hamata Z, Dogas Z. Excitability of contralateral and ipsilateral projections of corticobulbar pathways recorded as corticobulbar motor evoked potentials of the cricothyroid muscles. Clin Neurophysiol. 2015 Aug;126(8):1570-7. doi: 10.1016/j.clinph.2014.11.001. Epub 2014 Nov 8.

  PMID: 25481338 BACKGROUND

MeSH Terms

Conditions

Dysphonia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Maja Rogić Vidaković, PhD

  University of Split, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maja Rogić Vidaković, PhD

CONTACT

+385098508210; maja.rogic@mefst.hr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 14, 2022
• Study Start: October 10, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2025
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

CR (1)