se of electrical stimulation to control adductory spasmodic dysphonia (AdSD) symptoms

Phase 1

• Conditions: G24.8; Other dystonia

• Registration Number: DRKS00022478
• Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-23
• Study Completion: 2022-03-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

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

- 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

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 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.