Cortical Silent Period in Laryngeal Dystonia (cSPDystonia)

September 28, 2023 updated by: Maja Rogić Vidaković, University of Split, School of Medicine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Transcranial magnetic stimulation (TMS)-induced cSP provide a noninvasive "in vivo" insight into how the human motor cortical inhibitory pathway function by generating electric current at a specific brain area through electromagnetic induction. The stimulator generates a changing electric current within the coil, which induces a magnetic field that then causes a second inductance of inverted electric charge within the brain itself. A single supra-threshold pulse of TMS over the human motor cortex elicits multiple descending volleys (I-waves) that generate a motor evoked potential (MEP) followed by a period of electromyographic silence in the tonically contracted target muscle (cSP). To date, methodologies for mapping the primary motor cortex (M1) with TMS and intraoperatively by electrical stimulation techniques have been previously developed to record corticobulbar motor evoked potentials (MEP) from laryngeal muscles. Except for estimating the amplitude and latency of MEPs recorded from laryngeal muscles, the cSP was investigated from thyroarytenoid muscle (TA) as a measure of M1 excitability in the TMS study. Previous work using TMS has indicated reduced inhibition to be characteristic of focal laryngeal dystonia. According to investigators' knowledge, cSP from other laryngeal muscles other than TA has not been investigated so far.

The proposed study analyses neurophysiological CNS data, including motor evaluation of corticospinal and corticobulbar pathways by recording MEPs and cSP using TMS.

Firstly, a questionnaire will be given to check for any previous neurological conditions, and subjects will provide signatures on participation in the study. The MRI of the subject's brain will be performed, and then 3D reconstructed for the use of TMS. The evaluation of the MRI will be done by radiologists at University Hospital Split. With the subject comfortably seated, the MRI is co-registered to the subject's head using the tracking system with TMS's unique forehead tracker. After TMS measurement of the MEP and cSP of CT muscle of individual subjects will be recorded. Data collected will be analyzed using MATLAB 2022a (MathWorks, USA). Measurements and data evaluation will be performed at the School of Medicine University in Split.

An otorhinolaryngology specialist will be consulted for the correct placement of the recording electrodes (Hookwire IOM electrodes, disposable subdermal needle electrode, 0.4 x 13 mm, SGM d.o.o, G. Novaka 22 a, 21000 Split, Croatia) into the CT muscle.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • Recruiting
        • University of Split School of Medicine
        • Contact:
          • Maja Rogić Vidaković, PhD
        • Principal Investigator:
          • Ivan Konstantinović, MD
        • Sub-Investigator:
          • Braco Bošković, MD
        • Sub-Investigator:
          • Sanda Pavelin, MD
        • Sub-Investigator:
          • Krešimir Dolić, Professor
        • Sub-Investigator:
          • Joško Šoda, Professor
        • Sub-Investigator:
          • Irena Bilić, MSLP
        • Sub-Investigator:
          • Željko Bušić, Professor
        • Sub-Investigator:
          • Marija Bušić, MD
        • Principal Investigator:
          • Maja Rogić Vidaković, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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

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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor evoked potential (MEP) latency
Time Frame: MEP latency evaluated on the first day of the arrival on TMS experiment
MEP latency is expressed in milliseconds
MEP latency evaluated on the first day of the arrival on TMS experiment
Motor evoked potential (MEP) amplitude
Time Frame: MEP amplitude evaluated on the first day of the arrival on TMS experiment
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)
Time Frame: cSP duration evaluated on the first day of the arrival on TMS experiment
cSP is expressed in milliseconds
cSP duration evaluated on the first day of the arrival on TMS experiment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

Collaborators

University Hospital of Split

Investigators

  • Principal Investigator: Maja Rogić Vidaković, PhD, University of Split, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003-08/22-03/0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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