Effects of Training on Central Auditory Function in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Electrophysiological Auditory Test
研究概览
简要总结
The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).
详细描述
Five general types of evaluations will be employed over multiple study sessions at the National Center for Rehabilitative Auditory Research (NCRAR). First, a neurologist will review the subject's medical history and perform a neurologic exam to confirm MS diagnosis. Second, peripheral auditory function will be evaluated using a standard set of routine audiometric tests. Additionally, subjects will complete a case history and series of hearing handicap inventories. Third, a battery of behavioral procedures will be used to characterize central auditory processing. Fourth, auditory evoked potential studies will be performed. Emphasis here will be upon evoked potentials whose putative neural generators lie within the central auditory nervous system. Fifth, subjects will receive magnetic resonance imaging (MRI) evaluation to determine sites and amount of neural degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 21-65 years;
- •a clinical or laboratory supported diagnosis of "definite" MS;
- •a diagnosis of relapsing-remitting, primary progressive, or secondary progressive MS;
- •a Kurtzke Expanded Disability Status Score (EDSS) of 0 to 7.0, inclusive;
- •no history of a clinical relapse or change in EDSS for three months preceding entry into the study; and
- •a brain MRI scan that shows at least three white-matter lesions on T2-weighted images consistent with MS
排除标准
- •current major disease or disorder other than MS (e.g., cancer, end-stage renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, diabetes);
- •other neurological conditions that could interfere with the ability to respond to tests and questionnaires;
- •non-native speaker of English (since test materials are presented in English);
- •pregnant (due to potential negative effects on the fetus during fMRI);
- •more than a mild degree (less than a 40 dB HL four-frequency pure-tone average [PTA]) of hearing loss bilaterally (since the presence of more than a mild degree of peripheral hearing impairment may impact CAP test results);
- •metal implants (due to fMRI constraints); and
- •left-handedness
研究组 & 干预措施
Non-MS Control
Non-MS control group
MS: Auditory Training
MS group receiving auditory training
干预措施: Auditory training (Behavioral)
MS: Control Activity
MS group not receiving auditory training, doing control activity
干预措施: MS: Control Activity (Other)
结局指标
主要结局
Electrophysiological Auditory Test
时间窗: Recordings were conducted during one session
auditory P300 amplitude in response to "rare" 1000 Hz tones
次要结局
- SCAN-A: Competing Words Test(Test administered during one session)
- Neural Magnetic Resonance Imaging (MRI)(Results were recorded during one scanning session)