Exploring the effects of surface electrostimulation toimprove the voice quality of patients suffering fromspasmodic dysphonia and/or voice tremor

Phase 1

Recruiting

• Conditions: G24.8; Other dystonia

• Registration Number: DRKS00023358
• Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.