Treatment of Chronic Bothersome Tinnitus Using Cognitive Training and D-cycloserine
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Missouri
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St. Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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
他の名前：
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プラセボコンパレーター：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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change from baseline in Tinnitus Handicap Inventory (THI)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in Neurocognitive assessment score
時間枠：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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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
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研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
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最終確認日
詳しくは
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Cognitive Trainingの臨床試験
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University of MinnesotaNational Institute of Mental Health (NIMH)完了精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
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University of Texas at Austin積極的、募集していない
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Douglas Mental Health University Institute積極的、募集していない
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VA Office of Research and Development募集
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University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了