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

21 de maio de 2013 atualizado por: Jay F. Piccirillo, MD, Washington University School of Medicine
The purpose of this research study is to determine if a medication along with a computer program designed to improve memory and other mental processes can help people like yourself with tinnitus. The medication that will be investigated, d-cycloserine, was developed as an antibiotic. However, more recently, research in other studies has shown that this medication may enhance learning and memory. The investigators would like to determine if computer programs designed to improve memory and attention are enhanced by this medication. In addition, the investigators hope to learn if the use of these programs can help participants with their tinnitus as well as their ability to remember and focus. All research participants will receive therapy with a computer-based program designed to improve memory and attention. Half of participants will also receive d-cycloserine while the other half of participants will receive placebo. The placebo is a sugar pill without active medication.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Tinnitus is the perception of a "ringing or hissing" sound in the absence of an acoustic stimulus affecting more than 40 million people in the United States. While the exact etiology of chronic bothersome tinnitus is unknown, current evidence based on numerous studies and neuroimaging results suggests chronic bothersome tinnitus involves the central nervous system with abnormalities in neural networks including attention and emotional networks. These neuroplastic changes in multiple neural networks may offer targets in the treatment of chronic bothersome tinnitus.

The Brain Fitness Program® (Posit Science Corporation, San Francisco, California) is a cognitive rehabilitation program that has been used in the treatment of schizophrenia and geriatric populations, and has been shown to have favorable results by reorganizing aberrant neural networks. Preliminary results from our team have shown improvements in tinnitus severity and cognitive functioning for participants with chronic bothersome tinnitus using this cognitive rehabilitation program.

Recent studies in numerous disorders have shown d-cycloserine (DCS) augments learning therapy programs by enhancing neuroplasticity. In addition, the adjuvant use of DCS with learning therapies has been found to accelerate symptom reduction decreasing the time-burden needed for learning therapies. Based on the belief that chronic bothersome tinnitus involves changes in malleable neural networks that can be targets of therapy and that DCS enhances neuroplasticity, the investigators hypothesize that adjuvant DCS with cognitive rehabilitation treatment may improve tinnitus severity and the cognitive deficits associated with chronic bothersome tinnitus.

This randomized-controlled trial will use an abbreviated cognitive rehabilitation program given for 5 weeks with DCS or placebo to evaluate the impact of a neuroplasticity-sensitizing drug on tinnitus symptom severity and cognitive performance among patients with chronic bothersome tinnitus. A positive result on this study will have numerous implications, including offering a new treatment option for chronic bothersome tinnitus with few known side effects and limited time commitment or cost.

Tipo de estudo

Intervencional

Inscrição (Real)

37

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Missouri
      • St. Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

35 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Participants must be between the ages of 35 and 65.
  • Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus for at least a duration of 6 consecutive months.
  • Participants must have bothersome tinnitus as defined by a THI ≥ 30.
  • Participants must have access to a computer for at least 60 minutes per day, 2 days per week, for five consecutive weeks.
  • Participants must be willing to work on the Brain Fitness Program® that will be provided at least 60 minutes per day, 2 days per week, for 5 consecutive weeks.
  • Participants must be willing to return for two treatment study visits during the first week after enrollment in the study and an additional study visit after 5 weeks.
  • Participants must be willing to complete the Brain Fitness Program® and other assessments as prescribed.
  • Participants must be able to read, write, and speak English fluently as the Brain Fitness Program, tinnitus assessments, and neurocognitive testing are written and administered in English.
  • Women of child-bearing age must agree to use a study-approved form of contraception and agree to not try to become pregnant during the duration of the study. If a participant becomes pregnant, they should inform the PI and will be immediately withdrawn from the study.
  • Participants must be able to provide valid informed consent.

Exclusion Criteria:

  • Participants with a tinnitus diagnosis related to a Workman's Compensation Claim or any other litigation-related situation.
  • Participants with tinnitus related to retrocochlear lesions, cochlear implants, or other unknown anatomic/structural lesions of the brain, skull base, temporal bone, or ear.
  • Participants with hearing impairment such that they are unable to hear the highest volume of the computer cognitive training program.
  • Participants with an active diagnosis of any acute or chronic central neurological condition including: Parkinson's disease, Multiple Sclerosis, Alzheimer's Disease, cerebral infarcts, traumatic brain injury, epilepsy, dementia, and/or a history of brain tumor(s).
  • Subjects who have an active diagnosis of an anxiety disorder, psychosis or any psychiatric co-morbidity that may complicate the interpretation of study results.
  • Participants with symptoms of severe depression on the Patient Health Questionnaire-9 (subjects who score >15 on the Patient Health Questionnaire-9 (PHQ-9) designed to screen for depression).
  • Active alcohol and/or drug dependence or history of alcohol and/or drug dependence within the last year.
  • Participants with kidney or liver impairment, a heart condition, porphyria, porphyria among family members, or an allergy to DCS.
  • Participants who take any medication that is contraindicated with DCS.
  • Use of any medications that may alter or affect cognition including, but not limited to, sedatives, hypnotics, narcotics, and opiates.
  • Women who are pregnant or breast-feeding.
  • People who have ever used the Brain Fitness Program® or any other computer based Brain Exercise or Brain Training programs within the prior year.
  • Use of Neuromonics device for tinnitus treatment, or currently undergoing Tinnitus Retraining (TRT) program.
  • Any condition the PI determines would render the study to not be in the best interest of the patient.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: d-cycloserine
d-cycloserine 250 mg two days per week one hour prior to(cognitive training)
250 mg d-cycloserine or placebo taken orally one hour before Brain Fitness Program
Outros nomes:
  • Posit Science, Brain Fitnesss Program
Comparador de Placebo: Placebo
Placebo pill two days per week 1 hour prior to cognitive training
250 mg d-cycloserine or placebo taken orally one hour before Brain Fitness Program
Outros nomes:
  • Posit Science, Brain Fitnesss Program

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in Tinnitus Handicap Inventory (THI)
Prazo: Baseline and 5 weeks later
We will measure THI before and after treatment. Primary efficacy is defined by a decrease of 17 points on their THI from baseline.
Baseline and 5 weeks later

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Neurocognitive assessment score
Prazo: Baseline and 5 weeks later
We will measure PASAT, Stroop, and a newly designed neurocognitive computer based test at the patient's baseline visit and final visit. These assessments are done as patients with tinnitus frequently report cognitive difficulties in attention and memory. One aim of this study is to target these cognitive difficulties. Improvements in memory and attention will be assessed using these neurocognitive tests.
Baseline and 5 weeks later

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2012

Conclusão Primária (Real)

1 de abril de 2012

Conclusão do estudo (Real)

1 de junho de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

25 de janeiro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de março de 2012

Primeira postagem (Estimativa)

12 de março de 2012

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

23 de maio de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de maio de 2013

Última verificação

1 de maio de 2013

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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