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

This study has been completed.
Sponsor:
Information provided by:
ANM Adaptive Neuromodulation GmbH
ClinicalTrials.gov Identifier:
NCT00927121
First received: June 22, 2009
Last updated: April 18, 2012
Last verified: April 2012

June 22, 2009
April 18, 2012
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Complete list of historical versions of study NCT00927121 on ClinicalTrials.gov Archive Site
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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

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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Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Chronic Tonal Tinnitus
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 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00927121
09/1525
Yes
Central Coordinating investigator: Prof. Dr. Dr. Peter Tass, Research Center Jülich, Institute for Neurosciences and Medicine
ANM Adaptive Neuromodulation GmbH
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ANM Adaptive Neuromodulation GmbH
April 2012

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