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
  Purpose

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.

Condition Intervention Phase
Chronic Tonal Tinnitus
Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus

Resource links provided by NLM:


Further study details as provided by ANM Adaptive Neuromodulation GmbH:

Enrollment: 63
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927121

Locations
Germany
Research Center Jülich // Institute for Neurosciences and Medicine - Research Center
Jülich, Germany, 8185
Sponsors and Collaborators
ANM Adaptive Neuromodulation GmbH
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Central Coordinating investigator: Prof. Dr. Dr. Peter Tass, Research Center Jülich, Institute for Neurosciences and Medicine
ClinicalTrials.gov Identifier: NCT00927121     History of Changes
Other Study ID Numbers: 09/1525
Study First Received: June 22, 2009
Last Updated: April 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014