Evaluation of the therapeutic effects of surface electrostimulation on patients suffering from blepharospasm

Phase 1

• Conditions: G24.5; Blepharospasm

• Registration Number: DRKS00024499
• Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Age = 18 years
- Patients diagnosed with focal, primary bilateral BEB, independently whether their symptoms improve upon previous Botulin toxin injections
- The effects of any previous treatments, including but not limited to Botulin toxin injection shall be completely faded at the time of enrolment
- Patients who developed anti-BTX antibodies are not excluded
- Signed and dated informed consent before the start of any clinical investigation-specific procedure for all the recruited subjects

Exclusion Criteria

- Lack of compliance with any inclusion criteria
- Secondary BEB
- Unilateral BEB
- Lesion of the N. oculomotorius or of any other facial nerves
- Patients suffering from neurodegenerative diseases
- Suffering from depression equivalent to a score of = 20 according to the Beck Depression Inventory (BDI)
- Suffering from psychological and or psychiatric diseases
- Pregnant or breast-feeding women
- DBS users
- Use of an active medical implant
- Patients who underwent a previous BEB-related surgery
- Patients suffering from hemi-facial spasm, segmental, multifocal CD or from the Meige syndrome
- Other clinical conditions that might result in alteration of the outcomes of this clinical investigation
- 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 bilateral surface electrical stimulation of ophthalmic branch of the trigeminus could reduce or even prevent the BEB-related symptoms occurrence. The stimulation performance will be assessed by means of the following outcome measures:<br>- Jankovic Rating Scale<br>- Blepharospasm Disability Index

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this clinical investigation is to determine whether the bilateral surface electrical stimulation of ophthalmic branch of the trigeminus could reduce or even prevent the BEB-related symptoms occurrence, according to the following outcome measures:<br>- Blepharospasm Severity Rating Scale (BSRS)<br>- Unified Dystonia Rating Scale (UDRS)<br>- Cervical Dystonia Questionnaire (CDQ-24)<br>- 3D-Video of facial movements<br>- 3D-Videos of cervical and head movements<br>The secondary objectives will be evaluated only descriptively and thus they won’t contribute to determine the success or the failure of the clinical investigation.