Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression

NCT01549145 | Completed

• 1 other identifier: EST-01-IL
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to evaluate the safety and efficacy of applying electrical stimulation on the promontorium (EPS) for the suppression of tinnitus in a sub-chronic stimulation regimen.

Conditions

Tinnitus

Keywords

Severe; Ongoing; Unilateral; present for more than 6 months

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Study efficacy evaluations will be based on the analysis of pre and post procedure tinnitus severity characteristics (THI, MML, Pitch matching and VAS values).

  2 months

Secondary Outcomes (1)

• Safety

  2 months

Study Arms (1)

NIMBUS multifunctional stimulator

EXPERIMENTAL

A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)

Device: Nimbus Multifunctional Stimulator

Interventions

Nimbus Multifunctional Stimulator DEVICE

A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)

NIMBUS multifunctional stimulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total score on the Handicap Inventory (THI) of at least 40.
• Visual scale over 5.
• Tinnitus origin is peripheral (related to long term noise exposure, or to a sudden exposure to a very loud noise etc.)
• Tinnitus is on-going; present for more than 50% of the time over the past 12 months.
• Unilateral tinnitus
• Tinnitus prevalent at least 12 months.
• Willingness to abstain from part taking in other, non-study procedures indicated to lessen tinnitus and/or its perception.
• Willing and able to refrain from engaging in activities or work involving loud noise exposure.
• Male or females 18-60 years of age

You may not qualify if:

• Prior history of sudden hearing loss and/or fluctuating hearing levels.
• Tinnitus prevalent more than 3 years.
• History of frequent middle ear infections
• Patient under immunosuppressant therapy
• Auditory nerve damage.
• Vestibular Schwannoma
• Cochlear implant.
• Pregnant or lactating.
• Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
• Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss.
• Not being physically or geographically capable of returning for scheduled follow-up visits.
• Any physical, psychological, or emotional disorder that would interfere with the planned surgical operations
• Mentally retarded, developmentally delayed or suffering from organic brain dysfunction.

Sponsors & Collaborators

• EstimME Ltd.: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Tinnitus; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: June 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 29, 2012

Record last verified: 2012-08

Locations

IL (1)