Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00927121
Recruitment Status : Completed
First Posted : June 24, 2009
Last Update Posted : April 19, 2012
Sponsor:
Information provided by:
ANM Adaptive Neuromodulation GmbH

Tracking Information
First Submitted Date  ICMJE June 22, 2009
First Posted Date  ICMJE June 24, 2009
Last Update Posted Date April 19, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00927121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation on the Acoustic Stimulation in the Treatment of Chronic Tinnitus
Official Title  ICMJE l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Tonal Tinnitus
Intervention  ICMJE 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

Study Arms  ICMJE
  • Active Comparator: Group 1 : G_1
    G_1: stimulation for 4 - 6 hours a day, 4 tones per sequence
    Intervention: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
  • Active Comparator: Group 2 :G_2
    G_2: stimulation for 4 - 6 hours a day with 12-tone sequences
    Intervention: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
  • 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
    Intervention: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
  • Active Comparator: Group 4 : G_4
    G_4: stimulation for 1 hour a day, 4 tones per sequence
    Intervention: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
  • Placebo Comparator: Group5 : G_5
    G_5: stimulation with placebo-tone
    Intervention: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2010)
63
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2009)
45
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00927121
Other Study ID Numbers  ICMJE 09/1525
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Central Coordinating investigator: Prof. Dr. Dr. Peter Tass, Research Center Jülich, Institute for Neurosciences and Medicine
Study Sponsor  ICMJE ANM Adaptive Neuromodulation GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ANM Adaptive Neuromodulation GmbH
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP