Safety and Feasibility of Transcranial Direct Current Stimulation to Enhance Auditory Rehabilitation in Cochlear Implant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number Eligible Patients Who Expressed Interest in the Study
研究概览
简要总结
This study aims to evaluate the safety and feasibility of transcranial direct current stimulation (tDCS) in combination with home-based auditory training therapy in cochlear implant (CI) patients. Changes in speech perception performance will also be evaluated.
详细描述
Participants will complete a 4 week web-based auditory training program while wearing a transcranial direct current stimulation device (tDCS). The customized auditory training program will be completed at home, in 20 - 30 minute sessions at least five times a week for four weeks. A customized learning and practice plan will be provided along with instructions on use of the tDCS device.
tDCS is a non-invasive brain stimulation technique that delivers low-intensity current via electrodes on the scalp to modify neuronal excitability in the underlying cortex. The tDCS system has customizable headgear with disposable, snap-in electrodes that are easy to apply at home without assistance.
Speech and hearing assessments will be completed prior to the start of auditory training, at the end of the 4 week training session, and again 6 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18 years of age
- •Patients with a Unilateral Cochlear Implant device in use for a minimum of 1 year
- •Sentence recognition scores (AzBio) below 65% and/or word recognition scores (CNC) are below 75% in the implanted ear for > one year following cochlear implantation.
- •Ability to access internet to conduct computer-based auditory trainings and weekly video visits with study team weeks 2-5
排除标准
- •Non-English speaking
- •Diagnosis (documented or self-reported) of a psychiatric or neurologic condition, or any other comorbidities that may interfere with the study or increase the level of risk (such as dementia, seizures, legal blindness, brain tumor)
- •Implants, other than CI, above collar bone level that may interact with delivery of tDCS
- •Inability to or unwillingness to use electronic devices/computers, participate in video visits, or make required visits
结局指标
主要结局
Number Eligible Patients Who Expressed Interest in the Study
时间窗: During the screening period of approximately 6 months
Number of Subjects Who Completed tDCS Training
时间窗: up to 7 months
Measured by total number of subjects enrolled who completed tDCS during auditory training
Number of Participants Who Demonstrated Competence of tDCS Training
时间窗: 1 month
Measured by provider observation during in-office and tele-visits
Number of Participants Who Reported Ease of Completing the Training Program
时间窗: 1 month
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
Number of Participants Who Reported an Adverse Event
时间窗: 30 days
Measured by daily diary survey completion.
Number of Participants Who Experienced Skin Irritation From Use of tDCS
时间窗: 6 months
Measured by provider visual exam of scalp. Skin tingling/warmth is a known side effect of stimulation.
Number of Subjects Who Experienced Abnormal Function of Cochlear Implant Device
时间窗: 6 months
Measured by telemetry assessment.
Communication Function as Measured by Speech, Spatial and Qualities of Hearing (SSQ12) Questionnaire
时间窗: Baseline, 1 month, 6 months
The SSQ12 questionnaire is scored as a mean of the 12 items, with a range of 0 to 10. A higher score indicates greater communication function.
Speech Perception Performance - Sentence Recognition in Quiet
时间窗: Baseline, 1 month, 6 month
Measured by word and sentence lists presented in quiet (AzBio Quiet). Average of two AzBio lists presented in quiet. Range of scores is from 0-100, with higher scores indicating higher speech perception performance.
Speech Perception Performance - Word Recognition Performance
时间窗: Baseline, 1 month, 6 month
Measured by 50-item CNC word list. CNC word lists are standardized sets of monosyllabic words used in audiology to assess speech recognition ability, particularly in cochlear implant users. Reported as a percentage (0-100%), with higher values indicating better word recognition.
Cochlear Implant Quality of Life-35 Profile (CIQOL35) Questionnaire
时间窗: Baseline, 1 month, 6 months
The CIQOL35 raw score is calculated by summing the items for each domain. In this case, the raw score for the Global 10 domain is reported. The range in raw scores is 10-50, where a higher score indicates great quality of life.
次要结局
- Number of Participants Who Enjoyed Doing the Listening Exercises on the Computer(1 month)
- Number of Participants Who Reported Use of the Stimulation Device to be Acceptable(1 month)
- Number of Participants Who Reported Improvement in Hearing Performance(1 month)
- Number of Participants Who Would Recommend the Training Program(1 month)
- Number of Participants Who Reported Acceptable Compensation for Study Participation(1 month)