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

This study has been completed.
Sponsor:
Collaborator:
Ceres GmbH evaluation & research
Information provided by (Responsible Party):
ANM Adaptive Neuromodulation GmbH
ClinicalTrials.gov Identifier:
NCT01435317
First received: August 31, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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

Condition Intervention Phase
Tinnitus
Device: ANM T30 CR®-System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Clinical Study for Confirmation of Efficacy and Safety of Acoustic CR®-Neuromodulation by CE Marked ANM T30 CR®-System in a "Real Life" Patient Population With Chronic Tonal Tinnitus

Resource links provided by NLM:


Further study details as provided by ANM Adaptive Neuromodulation GmbH:

Primary Outcome Measures:
  • Improvement of TBF-12 Score or CGI Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.


Secondary Outcome Measures:
  • NRS loudness and annoyance (0-100) [ Time Frame: 0.5, 1, 2, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Tinnitus-freedom [ Time Frame: 3,6,9,12 months ] [ Designated as safety issue: No ]
  • Compliance [ Time Frame: 0.5,1,3,6,9,12 months ] [ Designated as safety issue: No ]
    Questioning if the specified application was kept.

  • Alteration of tinnitus [ Time Frame: 0.5,1,2,3,6,9,12 months ] [ Designated as safety issue: No ]
    Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System.

  • Audiogram for hearing loss change [ Time Frame: 3,12 months ] [ Designated as safety issue: No ]
  • TBF-12 [ Time Frame: 3,6,9,12 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: November 2011
Study Completion Date: July 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: standard
Standard treatment with the ANM T30 CR®-System
Device: ANM T30 CR®-System
Stimulation for 4-6h/day for a time of 1 year
Other Name: ANM T30 CR®-System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • symptomatic subjective tonal chronical (> 3 months) tinnitus
  • <60dB hearing loss
  • men and women ≥18 years old

Main Exclusion Criteria:

  • serious neurologic
  • psychiatric or internistic disease
  • objective tinnitus
  • Morbus Menière
  • craniomandibular triggered tinnitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435317

Locations
Germany
Dr. med. Mueller
Augsburg, Germany, 86167
Dr. med. Jan Loehler
Bad Bramstedt, Germany, 24576
Praxisverbund Berlin
Berlin, Germany, 10119
Dr. med. Daniel Osterland
Berlin, Germany, 10711
Dres. med. Bodlien/Lingner/Kassuhn
Braunschweig, Germany, 38100
Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann
Frankfurt, Germany, 60594
Dr. med. Fleissner
Freiburg, Germany, 79098
EuromedClinic
Fuerth, Germany, 90763
Dr. med. Hegemann-Gaertner
Grevenbroich, Germany, 41515
Dipl.-Med. Kathrin Stoelzer
Halle/Saale, Germany, 06108
Dr. med. Hahbrock
Koblenz, Germany, 56068
Praxis HNO Koeln Nord
Koeln, Germany, 50735
Dr. med. Wichmann
Krefeld, Germany, 47807
Roemerwallklini Gmbh
Mainz, Germany, 55131
HNO-Gemeinschaftspraxis im Zentrum
Mannheim, Germany, 68161
Dr .med. Tatjana von Stackelberg
Meerbusch, Germany, 40667
Dr. med. Ullmann
Melsungen, Germany, 34212
Dr. med. Wurzer
Muenchen, Germany, 80333
Dres. med. Bergmann und Davies
Nuertingen, Germany, 72622
Dr. med Uwe Brinkmann
Oelde, Germany, 59302
Dr. med. Huegelschaeffer
Philippsburg, Germany, 76661
Dr. med. Axel Roesler
Radevormwald, Germany, 42477
Dres. med. Ramming und Waller
Schweinfurt, Germany, 97421
Sponsors and Collaborators
ANM Adaptive Neuromodulation GmbH
Ceres GmbH evaluation & research
Investigators
Principal Investigator: Uwe Brinkmann, Dr. med. HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde
  More Information

No publications provided

Responsible Party: ANM Adaptive Neuromodulation GmbH
ClinicalTrials.gov Identifier: NCT01435317     History of Changes
Other Study ID Numbers: NCT2011-08-26
Study First Received: August 31, 2011
Last Updated: July 10, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ANM Adaptive Neuromodulation GmbH:
Acoustic CR®-neuromodulation
ANM T30 CR®-System

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014