NCT00927121

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

First QC Date

June 22, 2009

Last Update Submit

April 18, 2012

Conditions

Chronic Tonal Tinnitus

Study Arms (5)

Group 1 : G_1

ACTIVE COMPARATOR

G\_1: stimulation for 4 - 6 hours a day, 4 tones per sequence

Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset

Group 2 :G_2

ACTIVE COMPARATOR

G\_2: stimulation for 4 - 6 hours a day with 12-tone sequences

Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset

Group3 : G_3

ACTIVE COMPARATOR

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

Group 4 : G_4

ACTIVE COMPARATOR

G\_4: stimulation for 1 hour a day, 4 tones per sequence

Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset

Group5 : G_5

PLACEBO COMPARATOR

G\_5: stimulation with placebo-tone

Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset

Interventions

Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated resetDEVICE

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 1 : G_1Group 2 :G_2Group 4 : G_4Group3 : G_3Group5 : G_5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jülich, 8185, Germany

Location

Related Publications (2)

  • 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.

    PMID: 22414611RESULT

  • 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.

    PMID: 22846637DERIVED

Related Links

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 24, 2009

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

DE(1)