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

21. mai 2013 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

37

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Missouri
      • St. Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

35 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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
Andre navn:
  • Posit Science, Brain Fitnesss Program
Placebo komparator: 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
Andre navn:
  • Posit Science, Brain Fitnesss Program

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in Tinnitus Handicap Inventory (THI)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Neurocognitive assessment score
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2012

Primær fullføring (Faktiske)

1. april 2012

Studiet fullført (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først innsendt

25. januar 2012

Først innsendt som oppfylte QC-kriteriene

9. mars 2012

Først lagt ut (Anslag)

12. mars 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. mai 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2013

Sist bekreftet

1. mai 2013

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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