Clinical trial NCT05580302: Cortical Silent Period in Laryngeal Dystonia
Official title: Cortical Silent Period in Laryngeal Dystonia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Laryngeal Dystonia
Spasmodic Dysphonia
Keywords: laryngeal dystonia
cortical silent period
spasmodic dysphonia
transcranial magnetic stimulation
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
Collaborators: name: University Hospital of Split
First posted: 2022-10-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Motor evoked potential (MEP) latency
timeFrame: MEP latency evaluated on the first day of the arrival on TMS experiment
measure: Motor evoked potential (MEP) amplitude
timeFrame: MEP amplitude evaluated on the first day of the arrival on TMS experiment
measure: Duration of cortical silent period (cSP)
timeFrame: cSP duration evaluated on the first day of the arrival on TMS experiment
Secondary outcomes:
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University of Split School of Medicine
Study officials:
affiliation: University of Split, School of Medicine
name: Maja Rogić Vidaković, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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