Clinical Investigation on the Acoustic Stimulation in the Treatment of Chronic Tinnitus

There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely. Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there is still a need of new treatments that can reduce considerably the tinnitus symptoms and improve the QOL of subjects.

Trial objectives:

* The aim of this trial is the improvement of the QOL (quality of live) by reducing the Tinnitus- Symptoms of the patient. * To confirm the efficacy and safety of the coordinated reset technology.

These objectives will be assessed:

* By subjective and objective measurements of the Tinnitus symptoms, loudness and annoyance.

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Key information

Conditions

Chronic Tonal Tinnitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Center Jülich // Institute for Neurosciences and Medicine - Research Center

Jülich, 8185, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Mentally healthy people
Chronic tonal Tinnitus
Older than 18 years
Signature of the patient informed consent
No participation in other tinnitus therapy during the clinical investigation

Exclusion criteria

A necessity for hearing aid
Auditory hallucination
Symptomatic hearing disorders
"Morbus Meniere",
Tinnitus due to temporomandibular joint disorders
Subjects who can't perceive therapeutic tones
Brainstem diseases
Psychiatric disorders
Objective Tinnitus
Insufficient treatment of general disorders, anemia, tumor, dialysis, hypertonus ect.

Treatment and study plan

Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset

Device

The CR-stimulation was originally developed by Prof. Dr. Dr. Peter Tass for deep brain stimulation (DBS). The CR-stimulation through high frequency short pulses causes a neuronal reorganization in the stimulated brain area establishing a normal neuronal activity.

Based on intensive modeling studies, experimental proof of concept (POC) animal studies and a clinical POC, we proved that the pathologic activity can be recuperated to a desynchronized/healthy state with the acoustic CR-stimulation.

The acoustic CR-stimulation signal will be generated by the ANM CR-Stimulator and transmitted to the ears through a speaker system

Sponsors and collaborators

Lead sponsor

ANM Adaptive Neuromodulation GmbH

Industry

Registry information

Official study title

l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus

Important dates

First posted: Jun 24, 2009
Registry last updated: Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.