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Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")

NCT01435317 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-07-11

No results posted yet for this study

Summary

Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient setting.

* Identification of early indicators for therapy success
* Comparison of different patient groups regarding: tinnitus severity, tinnitus duration, level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex forms
* Representative set of safety data in a broad patient spectrum
* Measurement of tinnitus burden (TBF-12 Questionnaire)
* Generation of longterm compliance data

Conditions

  • Tinnitus

Interventions

DEVICE

ANM T30 CR®-System

Stimulation for 4-6h/day for a time of 1 year

Sponsors & Collaborators

  • CERES GmbH

    collaborator INDUSTRY

  • ANM Adaptive Neuromodulation GmbH

    lead INDUSTRY

Principal Investigators

  • Uwe Brinkmann, Dr. med. · HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-06-30
Completion
2014-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01435317 on ClinicalTrials.gov