Evidence map›Paper›PMID 25356570›Full record

Trial reportJAMA otolaryngology-- head & neck surgery2015

A novel treatment for tinnitus and tinnitus-related cognitive difficulties using computer-based cognitive training and D-cycloserine.

James G Krings, Andre Wineland, Dorina Kallogjeri, Thomas L Rodebaugh, Joyce Nicklaus, Eric J Lenze, Jay F Piccirillo

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in JAMA otolaryngology-- head & neck surgery, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01550796 (Treatment of Chronic Bothersome Tinnitus Using Cognitive Training and D-cycloserine), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 37% 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.

NCT01550796 phase2completednot on this map

Treatment of Chronic Bothersome Tinnitus Using Cognitive Training and D-cycloserine

TypeinterventionalSponsorWashington University School of MedicineRan2012 to 2012Enrolled37ConditionsTinnitusArmsCognitive Training
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Testing A Hypothesis: Tinnitus Control by Enhancing Physiological Inhibition.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2022
    Article
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  8. Article
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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

7 authors at 1 institution in 1 country.

James G KringsDepartment of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St Louis, Missouri2Doris Duke Clinical Research Fellowship, Washington University School of Medicine, St Louis, Missouri3Stanford Medical Scholars Fellowship, St.
Andre WinelandDepartment of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St Louis, Missouri.
Dorina KallogjeriDepartment of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St Louis, Missouri.
Thomas L RodebaughDepartment of Psychology, Washington University in St Louis, St Louis, Missouri.
Joyce NicklausDepartment of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St Louis, Missouri.
Eric J LenzeDepartment of Psychiatry, Washington University School of Medicine, St Louis, Missouri.
Jay F PiccirilloDepartment of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St Louis, Missouri.
Washington University in St. Louis · US

Funding

DEVELOPMENT OF CLINICIAN/RESEARCHERS IN ACADEMIC ENTT32DC000022 · NIDCD · WASHINGTON UNIVERSITY · PI PICCIRILLO, JAY F. · 1989 to 2022
$5.6M
Washington University Institute of Clinical and Translational SciencesTL1TR000449 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$2.5M
NCATS NIH HHS TL1 TR000449NIDCD NIH HHS T32 DC000022
6 · The paper itself

Abstract

importanceTinnitus affects more than 40 million people in the Unites States, and cognitive difficulties are among the most commonly associated symptoms.

objectiveTo test the feasibility and preliminarily the effectiveness of using a putative neuroplasticity-enhancing drug, D-cycloserine, to facilitate a computer-assisted CT program for improving tinnitus bother and related cognitive difficulties. DESIGN, SETTING, AND

participantsDouble-blind, randomized clinical trial at an outpatient academic medical center of 34 participants aged 35 to 65 years with subjective, unilateral or bilateral, nonpulsatile tinnitus of at least 6 months' duration.

interventionsFive weeks of twice-weekly computer-based CT with either 250 mg D-cycloserine or placebo orally prior to computer CT sessions. MAIN OUTCOMES AND MEASURES: Difference in the change in Tinnitus Functional Index (TFI) score between the 2 groups.

resultsAfter excluding 1 participant lost to follow-up, 1 who withdrew, 1 who did not complete 90% of sessions, and 1 outlier, 30 participants were included in the analysis. The D-cycloserine plus CT group showed a significant improvement in median TFI score (-5.8 [95% CI, -9.4 to -1.1]) and self-reported cognitive deficits (-4.5 [95% CI, -11.5 to -1.0]), but the placebo group did not (-1.0 [95% CI, -11.7 to 4.9] and -2.0 [95% CI, -5.1 to 2.0], respectively). After controlling for age and duration of tinnitus, there was no significant difference in TFI score change between the 2 groups (P = .41). After confounders were controlled for, the D-cycloserine group demonstrated a significantly greater improvement in self-reported cognitive deficits as compared with the placebo group (P = .03). No serious adverse events were reported. CONCLUSIONS AND RELEVANCE: Use of a computer-based CT program with a putative neuroplasticity-sensitizing drug, D-cycloserine, was feasible and well tolerated. With the limited sample size, the adjuvant use of D-cycloserine was no more effective than placebo at improving tinnitus bother. The finding that D-cycloserine use was more effective than placebo at improving self-reported cognitive difficulties could be important given the high rate of concern for cognitive deficits in patients with tinnitus. D-cycloserine and other putative neuroplasticity-facilitating agents could be investigated in the future as a strategy to enhance neuroplasticity-based tinnitus treatments.

trial registrationclinicaltrials.gov Identifier: NCT01550796.

Indexed as

Cognitive Behavioral TherapyAdultAgedCognition DisordersCycloserineDouble-Blind MethodFeasibility StudiesFemaleHumansMaleMiddle AgedPatient ComplianceTinnitusCycloserine

Identifiers

PMID25356570
PMCPMC5514293
OpenAlexW2086631277

What OpenQuestion holds

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Registered trials

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.