G24.8
Conditions
Interventions
Group 1: The stimulation will be delivered with a frequency of 60 Hz. The amplitude can vary between 0.1 and 30 mA. The setting will be used to determine the:
• Sensitivity threshold
• Discomfort th
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 or abductory SD, and/or voice tremor, independently whether their symptoms improve upon previous Botulin injections - The effects of any previous treatments, including but not limited to Botulin injection shall be completely faded at the time of the first stimulation - Aging voice, cervical dystonia, supraglottal hyperactivity, or glottal hypoactivity do not constitute an exclusion criterion for the enrollment in this study as long as correctly and accurately described - 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 treatment 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. Chronic Obstructive Pulmonary Disease (COPD) grade II or higher) - Other clinical conditions that might result in alteration of the outcomes of this clinical investigation other than those listed in the inclusion criteria - 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 2020CIP004 - 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 bilateral surface stimulation of the ILMs is able to reduce the voice strain when the last post-stimulation test results (CS3 Post-stim) are compared with their results at baseline. The analysis will assess separately the results obtained by the SD and VT patients. Voice improvement will be assessed by analyzing the voice strain when the patient reads a list of 10 vowel-rich sentences at the 3 final checkpoints, and comparing it with the voice strain obtained at Baseline_zero. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this clinical investigation is to further analyze the effects of the tested stimulation protocol on the voice quality of the assessed patients by means of the following standardized outcome measures commonly used to evaluate voice disorders: - Voice strain analysis based on the off-line evaluation of the audiofile recording the patient reading 10 vowel-rich sentences at normal pitch - Spasm number calculation based on the off-line evaluation of the audiofile recording the patient reading 10 vowel-rich sentences at normal pitch - Voice tremor assessment 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 - Sound Pressure Level (SPL) range from SPLmax and SPLmin, measured during the VRP assessment - Fundamental frequency (F0) range from F0max and F0min, measured during the VRP assessment - Maximum Phonation Time (MPT) measured on [a:] during the VRP assessment - Jitter measured during the VRP assessment - Dysphonia Severity Index (DSI) measured during the VRP assessment - Roughness, Breathiness, Hoarseness (RBH) evaluated on the audiofile with the patient reading at normal pitch the standard text “The Northern Wind and the Sun” - F0 measured during the reading of 10 vowel-rich sentences at normal pitch - Duration of the reading of each vowel-rich sentence based on the off-line evaluation of the audiofile recording the patient reading 10 vowel-rich sentences at normal pitch - Voice Handicap Index (VHI-9i) - Sydney Swallow Questionnaire (SSQ) - Glasgow Benefit Inventory (GBI) and by means the following non-standardized outcome measures: - Overall phonation effort estimation - Communicative Participation Item Bank (CPIB) - short form - Voice Problems Questionnaire (VPQ) - Symptoms form for the subjective assessment of SD/Voice tr | — |
Countries
Austria, Germany, Ukraine
Contacts
Public ContactPia Plattner
MED-EL Elektromedizinische Geräte GmbH
Outcome results
None listed