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

Chronic Tonal Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927121
• Other study ID #: 09/1525
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 22, 2009
• Last updated: April 18, 2012

Study information

• Verified date: April 2012
• Source: ANM Adaptive Neuromodulation GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Tonal Tinnitus
• Tinnitus

Intervention

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

Locations

Country	Name	City	State
Germany	Research Center Jülich // Institute for Neurosciences and Medicine - Research Center	Jülich

Sponsors (1)

Lead Sponsor	Collaborator
ANM Adaptive Neuromodulation GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Tass PA, Adamchic I, Freund HJ, von Stackelberg T, Hauptmann C. Counteracting tinnitus by acoustic coordinated reset neuromodulation. Restor Neurol Neurosci. 2012;30(2):137-59. doi: 10.3233/RNN-2012-110218. — View Citation