search
Back to results

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

Primary Purpose

Chronic Tonal Tinnitus

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
Sponsored by
ANM Adaptive Neuromodulation GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tonal Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Center Jülich // Institute for Neurosciences and Medicine - Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group 1 : G_1

Group 2 :G_2

Group3 : G_3

Group 4 : G_4

Group5 : G_5

Arm Description

G_1: stimulation for 4 - 6 hours a day, 4 tones per sequence

G_2: stimulation for 4 - 6 hours a day with 12-tone sequences

G_3: stimulation for 4 - 6 hours a day, 4 tones per sequence with a signal controlled by EEG measurement

G_4: stimulation for 1 hour a day, 4 tones per sequence

G_5: stimulation with placebo-tone

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 22, 2009
Last Updated
April 18, 2012
Sponsor
ANM Adaptive Neuromodulation GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT00927121
Brief Title
Clinical Investigation on the Acoustic Stimulation in the Treatment of Chronic Tinnitus
Official Title
l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ANM Adaptive Neuromodulation GmbH

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tonal Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 : G_1
Arm Type
Active Comparator
Arm Description
G_1: stimulation for 4 - 6 hours a day, 4 tones per sequence
Arm Title
Group 2 :G_2
Arm Type
Active Comparator
Arm Description
G_2: stimulation for 4 - 6 hours a day with 12-tone sequences
Arm Title
Group3 : G_3
Arm Type
Active Comparator
Arm Description
G_3: stimulation for 4 - 6 hours a day, 4 tones per sequence with a signal controlled by EEG measurement
Arm Title
Group 4 : G_4
Arm Type
Active Comparator
Arm Description
G_4: stimulation for 1 hour a day, 4 tones per sequence
Arm Title
Group5 : G_5
Arm Type
Placebo Comparator
Arm Description
G_5: stimulation with placebo-tone
Intervention Type
Device
Intervention Name(s)
Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
Intervention Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Research Center Jülich // Institute for Neurosciences and Medicine - Research Center
City
Jülich
ZIP/Postal Code
8185
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22414611
Citation
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.
Results Reference
result
PubMed Identifier
22846637
Citation
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.
Results Reference
derived
Links:
URL
http://iospress.metapress.com/content/r771875822464323/?p=c8cb085557f04bd0b9c22d1d2e9d3eb6&pi=0
Description
Counteracting tinnitus by acoustic coordinated reset neuromodulation. Tass PA, Adamchic I, Freund HJ, von Stackelberg T, Hauptmann C.

Learn more about this trial

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

We'll reach out to this number within 24 hrs