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

NCT01550796 | Completed Phase 2

• 1 other identifier: 201110105
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus

Keywords

Tinnitus; Brain Fitness Program; Posit Science; D-cycloserine; Cognitive Training

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Tinnitus Handicap Inventory (THI)

  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

Secondary Outcomes (1)

• Change in Neurocognitive assessment score

  Baseline and 5 weeks later

Study Arms (2)

d-cycloserine

ACTIVE COMPARATOR

d-cycloserine 250 mg two days per week one hour prior to(cognitive training)

Behavioral: Cognitive Training

Placebo

PLACEBO COMPARATOR

Placebo pill two days per week 1 hour prior to cognitive training

Behavioral: Cognitive Training

Interventions

Cognitive Training BEHAVIORAL

250 mg d-cycloserine or placebo taken orally one hour before Brain Fitness Program

Also known as: Posit Science, Brain Fitnesss Program

Placebo; d-cycloserine

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (12)

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• 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.

  PMID: 19448187 BACKGROUND

• 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.

  PMID: 20599140 BACKGROUND

• 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).

  PMID: 16411806 BACKGROUND

• Kaltenbach JA. Neurophysiologic mechanisms of tinnitus. J Am Acad Audiol. 2000 Mar;11(3):125-37.

  PMID: 10755809 BACKGROUND

• Lenarz T, Schreiner C, Snyder RL, Ernst A. Neural mechanisms of tinnitus. Eur Arch Otorhinolaryngol. 1993;249(8):441-6. doi: 10.1007/BF00168851.

  PMID: 8442938 BACKGROUND

• 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.

  PMID: 12239260 BACKGROUND

• Lockwood AH, Salvi RJ, Burkard RF, Galantowicz PJ, Coad ML, Wack DS. Neuroanatomy of tinnitus. Scand Audiol Suppl. 1999;51:47-52.

  PMID: 10803913 BACKGROUND

• 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.

  PMID: 20670725 BACKGROUND

• 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.

  PMID: 21377691 BACKGROUND

• 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.

  PMID: 19220558 BACKGROUND

• 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.

  PMID: 25356570 DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jay F Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology, Director of Clinical Outcomes Research Office

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: March 12, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

US (1)