G24.8
Conditions
Interventions
Group 1: After the baseline session the stimulation will be performed continuously for 30 min. After 15 min of continuous stimulation, and when the stimulation is still applied, the patient will be as
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age = 18 years - Patients diagnosed with adductory Spasmodic Dysphonia, under successful botulin toxin treatment (i.e. they experienced a clinical benefit from previous botulin toxin injections within the last year), who at the time of enrolment need again a botulin toxin injection - Signed and dated informed consent before the start of any clinical investigationspecific procedure for all the recruited subjects
Exclusion criteria
Exclusion criteria: - Lack of compliance with any inclusion criteria - Pregnant or breast-feeding women - Patients for whom the previous botulin toxin injection is still effective at the time of enrolment - Patients who underwent a permanent laryngeal surgery - Patients with chronic upper airway infections or severe respiratory diseases (e.g. COPD grade II or higher) - Patients with diagnosed CNS diseases - Patients suffering from any other voice disorders in addition to SD (e.g. voice tremor, supraglottic hyperactivity, other types of dystonia, etc.) - Other clinical conditions that might result in alteration of the outcomes of this clinical investigation (e.g. ageing voice) - Use of an active medical implant - Known allergies or intolerance to the material used for this clinical investigation - Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of the clinical investigation - Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this clinical investigation is to determine whether the protocol for iSLN electrostimulation can improve the AdSD symptoms, evaluated according to the number of spasms when the patient read 10 vowel-rich sentences at normal pitch. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this clinical investigation is to further analyze the effects of the iSLN electrostimulation on the AdSD symptoms by means of the following standardized outcome measures commonly used to evaluate voice disorders: - Jitter measured during the VRP assessment - SPL range measured during the VRP assessment - F0 range measured during the VRP assessment - F0 measured during the reading of 10 vowel-rich sentences at normal pitch - Voice strain analysis based on the off-line evaluation of the audiofile recording the patient reading 10 vowel-rich sentences at normal pitch - Vowel analysis based on the off-line evaluation of the audiofile recording the patient sustaining each vowel for a maximum of 5s Jitter measured during the VRP assessment - MPT measured on [a:] during the VRP assessment - DSI measured during the VRP assessment - RBH - Videolangoscopy and -stroboscopy - VHI-9i - Sydney Swallow Questionnaire (SSQ) - GBI and by means the following non-standardized outcome measures: - Overall phonation effort estimation - CPIB - short form - Voice Problems Questionnaire (VPQ) | — |
Countries
Austria, Germany, Ukraine
Contacts
Public ContactTadeus Nawka
Charité Universitätsmedizin Berlin
Outcome results
None listed