Laryngeal DystoniacSPDystoniaNCT05580302
Cortical Silent Period in Laryngeal Dystonia
An observational study of Laryngeal Dystonia and Spasmodic Dysphonia, run by University of Split, School of Medicine at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Laryngeal Dystonia, Spasmodic Dysphonia
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteCroatia
- Study dates
- 10 Oct 2022to 31 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- adults (18-65 years old), no implanted metals in the body (e.g. pacemaker, metal prosthesis in the skull and oral cavity).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University of Split School of Medicine
Split, 21000
Maja Rogić Vidaković, PhD
Ivan Konstantinović, MD
About this study
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.
Read the 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.
- Conditions
- Laryngeal Dystonia, Spasmodic Dysphonia
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Keywords
- laryngeal dystonia, cortical silent period, spasmodic dysphonia, transcranial magnetic stimulation
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potential (MEP) latency
MEP latency is expressed in milliseconds
Measured: MEP latency evaluated on the first day of the arrival on TMS experiment
Motor evoked potential (MEP) amplitude
MEP amplitude is expressed in microvolts
Measured: MEP amplitude evaluated on the first day of the arrival on TMS experiment
Duration of cortical silent period (cSP)
cSP is expressed in milliseconds
Measured: cSP duration evaluated on the first day of the arrival on TMS experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start10 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Laryngeal DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Split
- Responsible party
- Principal investigator, Maja Rogić Vidaković, University of Split, School of Medicine
- Investigators
- Maja Rogić Vidaković, PhD, Principal investigator, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580302
- Sponsor's protocol ID
- 003-08/22-03/0003
- Acronym
- cSPDystonia
- Status last verified
- Sep 2023
- First submitted
- 10 Oct 2022
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request.
Publications
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.
PubMed 26200329Pirio 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.
PubMed 28077492Deletis 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.
PubMed 24613682Chen 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.
PubMed 28326007Chen 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.
PubMed 32289724Rossini 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.
PubMed 25797650Simonyan 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.
PubMed 33858994Rogic 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.
PubMed 25481338
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Silent Period in Laryngeal Dystonia
- ClinicalTrials.gov ID
- NCT05580302
- Acronym / sponsor ID
- cSPDystonia / 003-08/22-03/0003
- Conditions
- Laryngeal Dystonia, Spasmodic Dysphonia
- Keywords
- laryngeal dystonia, cortical silent period, spasmodic dysphonia, transcranial magnetic stimulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Collaborators
- University Hospital of Split
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal Dystonia | – | Other: Transcranial Magnetic Stimulation (TMS)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. |
| Healthy subjects | – | Other: Transcranial Magnetic Stimulation (TMS)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- adults (18-65 years old), no implanted metals in the body (e.g. pacemaker, metal prosthesis in the skull and oral cavity).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Healthy subjects, Laryngeal Dystonia |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Background: PubMed 26200329Blitzer 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.
- Background: PubMed 28077492Pirio 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.
- Background: PubMed 24613682Deletis 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.
- Background: PubMed 28326007Chen 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.
- Background: PubMed 32289724Chen 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.
- Background: PubMed 25797650Rossini 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.
- Background: PubMed 33858994Simonyan 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.
- Background: PubMed 25481338Rogic 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.
- Individual participant dataSharing planned: Undecided. Upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maja Rogić Vidaković, PhD principal investigator
University of Split, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Dystonia and Spasmodic Dysphonia, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maja Rogić Vidaković, PhD (+385098508210, maja.rogic@mefst.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor evoked potential (MEP) latency (time frame: MEP latency evaluated on the first day of the arrival on TMS experiment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05580302, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.