NCT00927121

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: ANM Adaptive Neuromodulation GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Tonal Tinnitus

Interventions

Type	Name	Description
DEVICE	Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset	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

Timeline

• First posted: 2009-06-24
• Last updated: 2012-04-19

Locations

1 site across 1 country: Germany