Evidence map›Paper›PMID 26568958›Full record

Trial reportBioMed research international2015

Acoustic Coordinated Reset Neuromodulation in a Real Life Patient Population with Chronic Tonal Tinnitus.

Christian Hauptmann, Armin Ströbel, Mark Williams, Nitesh Patel, Hannes Wurzer, Tatjana von Stackelberg, Uwe Brinkmann, Berthold Langguth, Peter A Tass

Open access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in BioMed research international, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 2 countries.

Christian HauptmannInstitute of Neuroscience and Medicine-Neuromodulation (INM-7), Jülich Research Center, 52425 Jülich, Germany.
Armin StröbelCERES GmbH Evaluation & Research, 79539 Lörrach, Germany.
Mark WilliamsThe Tinnitus Clinic Inc., London W1G 6AX, UK.
Nitesh PatelThe Tinnitus Clinic Inc., London W1G 6AX, UK.
Hannes WurzerTinnitus Zentrum Promenadeplatz, 80333 München, Germany.
Tatjana von StackelbergEar, Nose and Throat (ENT) Center, 40667 Meerbusch, Germany.
Uwe BrinkmannEar, Nose and Throat (ENT) Clinic Hamm-Ahlen-Oelde, 59302 Oelde, Germany.
Berthold LangguthDepartment of Psychiatry and Psychotherapy, University of Regensburg, 93053 Regensburg, Germany.
Peter A TassInstitute of Neuroscience and Medicine-Neuromodulation (INM-7), Jülich Research Center, 52425 Jülich, Germany ; Department of Neurosurgery, Stanford University, Stanford, CA 94305, USA ; Department of Neuromodulation, University of Cologne, 50923 Cologne, Germany.
Forschungszentrum Jülich · DEUniversity of Regensburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePrimary tinnitus has a severe negative influence on the quality of life of a significant portion of the general population. Acoustic coordinated reset neuromodulation is designed to induce a long-lasting reduction of tinnitus symptoms. To test acoustic coordinated reset neuromodulation as a treatment for chronic, tonal tinnitus under real life conditions, an outpatient study "RESET Real Life" was commissioned by ANM GmbH. Herein we present the results of this study.

methodsIn a prospective, open-label, nonrandomized, noncontrolled multicenter clinical study with 200 chronic tinnitus patients, tinnitus questionnaire TBF-12 and Global Clinical Improvement-Impression Scale (CGI-I7) are used to study the safety and efficacy of acoustic coordinated reset neuromodulation. 189 patients completed the last 12-month visit, 11 patients dropped out (8 because of nontreatment related reasons; 2 because tinnitus did not change; and 1 because tinnitus got louder).

resultsAcoustic coordinated reset neuromodulation caused a statistically and clinically significant decrease in TBF-12 scores as well as in CGI-I7 after 12 months of therapy under real life conditions. There were no persistent adverse events reported that were related to the therapy.

conclusionThe field study "RESET Real Life" provides evidence for safety and efficacy of acoustic coordinated reset neuromodulation in a prospective, open-label, real life setting.

Indexed as

Acoustic StimulationChronic DiseaseFemaleGermanyHumansMaleMiddle AgedTinnitusTreatment Outcome

Identifiers

PMID26568958
PMCPMC4629059
OpenAlexW2134597626

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.