- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01550796
Treatment of Chronic Bothersome Tinnitus Using Cognitive Training and D-cycloserine
Descripción general del estudio
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Missouri
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St. Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: d-cycloserine
d-cycloserine 250 mg two days per week one hour prior to(cognitive training)
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250 mg d-cycloserine or placebo taken orally one hour before Brain Fitness Program
Otros nombres:
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Comparador de placebos: Placebo
Placebo pill two days per week 1 hour prior to cognitive training
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250 mg d-cycloserine or placebo taken orally one hour before Brain Fitness Program
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from baseline in Tinnitus Handicap Inventory (THI)
Periodo de tiempo: Baseline and 5 weeks later
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We will measure THI before and after treatment.
Primary efficacy is defined by a decrease of 17 points on their THI from baseline.
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Baseline and 5 weeks later
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Neurocognitive assessment score
Periodo de tiempo: Baseline and 5 weeks later
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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.
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Baseline and 5 weeks later
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.
- Fisher M, Holland C, Merzenich MM, Vinogradov S. Using neuroplasticity-based auditory training to improve verbal memory in schizophrenia. Am J Psychiatry. 2009 Jul;166(7):805-11. doi: 10.1176/appi.ajp.2009.08050757. Epub 2009 May 15.
- Henry JA, Dennis KC, Schechter MA. General review of tinnitus: prevalence, mechanisms, effects, and management. J Speech Lang Hear Res. 2005 Oct;48(5):1204-35. doi: 10.1044/1092-4388(2005/084).
- Shargorodsky J, Curhan GC, Farwell WR. Prevalence and characteristics of tinnitus among US adults. Am J Med. 2010 Aug;123(8):711-8. doi: 10.1016/j.amjmed.2010.02.015.
- Lockwood AH, Salvi RJ, Burkard RF. Tinnitus. N Engl J Med. 2002 Sep 19;347(12):904-10. doi: 10.1056/NEJMra013395. No abstract available.
- Choi DC, Rothbaum BO, Gerardi M, Ressler KJ. Pharmacological enhancement of behavioral therapy: focus on posttraumatic stress disorder. Curr Top Behav Neurosci. 2010;2:279-99. doi: 10.1007/7854_2009_10.
- Ganasen KA, Ipser JC, Stein DJ. Augmentation of cognitive behavioral therapy with pharmacotherapy. Psychiatr Clin North Am. 2010 Sep;33(3):687-99. doi: 10.1016/j.psc.2010.04.008.
- Kaltenbach JA. Neurophysiologic mechanisms of tinnitus. J Am Acad Audiol. 2000 Mar;11(3):125-37.
- Lenarz T, Schreiner C, Snyder RL, Ernst A. Neural mechanisms of tinnitus. Eur Arch Otorhinolaryngol. 1993;249(8):441-6. doi: 10.1007/BF00168851.
- Lockwood AH, Salvi RJ, Burkard RF, Galantowicz PJ, Coad ML, Wack DS. Neuroanatomy of tinnitus. Scand Audiol Suppl. 1999;51:47-52.
- Siegmund A, Golfels F, Finck C, Halisch A, Rath D, Plag J, Strohle A. D-cycloserine does not improve but might slightly speed up the outcome of in-vivo exposure therapy in patients with severe agoraphobia and panic disorder in a randomized double blind clinical trial. J Psychiatr Res. 2011 Aug;45(8):1042-7. doi: 10.1016/j.jpsychires.2011.01.020. Epub 2011 Mar 5.
- Krings JG, Wineland A, Kallogjeri D, Rodebaugh TL, Nicklaus J, Lenze EJ, Piccirillo JF. A novel treatment for tinnitus and tinnitus-related cognitive difficulties using computer-based cognitive training and D-cycloserine. JAMA Otolaryngol Head Neck Surg. 2015 Jan;141(1):18-26. doi: 10.1001/jamaoto.2014.2669.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201110105
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Ensayos clínicos sobre Tinnitus
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State University of New York at BuffaloUniversity at BuffaloTerminadoTinnitus Subjetivo | Tinnitus | Tinnitus inducido por ruido | Tinnitus, Objetivo | Tinnitus agravado | Tinnitus pulsátil | Tinnitus, Emisión Oto-Acústica Espontánea | Tinnitus, hacer clic | Tinnitus, tensor del tímpano inducidoEstados Unidos
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityAún no reclutando
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Merz Pharmaceuticals GmbHTerminadoTinnitus SubjetivoBélgica, República Checa, Francia, Polonia, Sudáfrica, Países Bajos
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Mohab MohammedAún no reclutandoTinnitus pulsátil (diagnóstico)
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Merz Pharmaceuticals GmbHTerminadoTinnitus SubjetivoAlemania, Portugal, España, Reino Unido, Austria
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Merz Pharmaceuticals GmbHTerminadoTinnitus SubjetivoEstados Unidos, Reino Unido, Polonia, Austria, Bélgica, Brasil, República Checa, Francia, Alemania, México, Países Bajos, Portugal, Sudáfrica, España
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityTerminadoTinnitus SubjetivoPorcelana
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Neurive Co.,Ltd.TerminadoTinnitus | Tinnitus SubjetivoCorea del Sur
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University of Sao PauloTerminado
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