Treatment of Chronic Bothersome Tinnitus Using Cognitive Training and D-cycloserine
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive Training
Intervention type(s): Behavioral
Intervention description(s): 250 mg d-cycloserine or placebo taken orally one hour before Brain Fitness Program
Other intervention name(s): Posit Science, Brain Fitnesss Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tinnitus; Brain Fitness Program; Posit Science; D-cycloserine; Cognitive Training