Clinical Investigation on the Acoustic Stimulation in the Treatment of Chronic Tinnitus
NCT ID: NCT00927121
Last Updated: 2012-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
63 participants
INTERVENTIONAL
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1 : G_1
G\_1: stimulation for 4 - 6 hours a day, 4 tones per sequence
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
Group 2 :G_2
G\_2: stimulation for 4 - 6 hours a day with 12-tone sequences
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
Group3 : G_3
G\_3: stimulation for 4 - 6 hours a day, 4 tones per sequence with a signal controlled by EEG measurement
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
Group 4 : G_4
G\_4: stimulation for 1 hour a day, 4 tones per sequence
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
Group5 : G_5
G\_5: stimulation with placebo-tone
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
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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ANM Adaptive Neuromodulation GmbH
INDUSTRY
Responsible Party
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Research Center Jülich, Institute for Neurosciences and Medicine
Locations
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Research Center Jülich // Institute for Neurosciences and Medicine - Research Center
Jülich, , Germany
Countries
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References
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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.
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.
Related Links
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Counteracting tinnitus by acoustic coordinated reset neuromodulation. Tass PA, Adamchic I, Freund HJ, von Stackelberg T, Hauptmann C.
Other Identifiers
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09/1525
Identifier Type: -
Identifier Source: org_study_id
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