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

April 18, 2012 updated by: ANM Adaptive Neuromodulation GmbH

l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Jülich, Germany, 8185
        • Research Center Jülich // Institute for Neurosciences and Medicine - Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 : G_1
G_1: stimulation for 4 - 6 hours a day, 4 tones per sequence
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
Active Comparator: Group 2 :G_2
G_2: stimulation for 4 - 6 hours a day with 12-tone sequences
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
Active Comparator: Group3 : G_3
G_3: stimulation for 4 - 6 hours a day, 4 tones per sequence with a signal controlled by EEG measurement
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
Active Comparator: Group 4 : G_4
G_4: stimulation for 1 hour a day, 4 tones per sequence
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
Placebo Comparator: Group5 : G_5
G_5: stimulation with placebo-tone
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANM Adaptive Neuromodulation GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 24, 2009

Study Record Updates

Last Update Posted (Estimate)

April 19, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/1525

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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