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

• ClinicalTrials.gov Identifier: NCT00927121
• Recruitment Status: Completed
• First Posted: June 24, 2009
• Last Update Posted: April 19, 2012
• Sponsor: ANM Adaptive Neuromodulation GmbH
• Information provided by: ANM Adaptive Neuromodulation GmbH

Study Description

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• 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

Arms and Interventions

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

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Counteracting tinnitus by acoustic coordinated reset neuromodulation. Tass PA, Adamchic I, Freund HJ, von Stackelberg T, Hauptmann C. 

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Adamchic I, Langguth B, Hauptmann C, Tass PA. Psychometric evaluation of visual analog scale for the assessment of chronic tinnitus. Am J Audiol. 2012 Dec;21(2):215-25. doi: 10.1044/1059-0889(2012/12-0010). Epub 2012 Jul 30.

• Responsible Party: Central Coordinating investigator: Prof. Dr. Dr. Peter Tass, Research Center Jülich, Institute for Neurosciences and Medicine
• ClinicalTrials.gov Identifier: NCT00927121
• Other Study ID Numbers: 09/1525
• First Posted: June 24, 2009
• Last Update Posted: April 19, 2012
• Last Verified: April 2012

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases