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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
8
Brain stimulation using low-intensity current via electrodes on scalp to modify neuronal excitability in the underlying cortex. The tDCS system has customizable head gear with disposable, snap-in electrodes wihich can be applied at home without assistance.
Web-based program uses consonant and vowel recognition and understanding sentences/conversations in quiet and in noise using different talkers, and other types of listening exercises.
Duke University Medical Center
Durham, North Carolina, United States
Number Eligible Patients Who Expressed Interest in the Study
Time frame: During the screening period of approximately 6 months
Number of Subjects Who Completed tDCS Training
Measured by total number of subjects enrolled who completed tDCS during auditory training
Time frame: up to 7 months
Number of Participants Who Demonstrated Competence of tDCS Training
Measured by provider observation during in-office and tele-visits
Time frame: 1 month
Number of Participants Who Reported Ease of Completing the Training Program
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
Time frame: 1 month
Number of Participants Who Reported an Adverse Event
Measured by daily diary survey completion.
Time frame: 30 days
Number of Participants Who Experienced Skin Irritation From Use of tDCS
Measured by provider visual exam of scalp. Skin tingling/warmth is a known side effect of stimulation.
Time frame: 6 months
Number of Subjects Who Experienced Abnormal Function of Cochlear Implant Device
Measured by telemetry assessment.
Time frame: 6 months
Speech Perception Performance - Sentence Recognition in Quiet
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.
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Time frame: Baseline, 1 month, 6 month
Speech Perception Performance - Word Recognition Performance
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.
Time frame: Baseline, 1 month, 6 month
Communication Function as Measured by Speech, Spatial and Qualities of Hearing (SSQ12) Questionnaire
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.
Time frame: Baseline, 1 month, 6 months
Cochlear Implant Quality of Life-35 Profile (CIQOL35) Questionnaire
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.
Time frame: Baseline, 1 month, 6 months
Number of Participants Who Enjoyed Doing the Listening Exercises on the Computer
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
Time frame: 1 month
Number of Participants Who Reported Use of the Stimulation Device to be Acceptable
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
Time frame: 1 month
Number of Participants Who Reported Improvement in Hearing Performance
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
Time frame: 1 month
Number of Participants Who Would Recommend the Training Program
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
Time frame: 1 month
Number of Participants Who Reported Acceptable Compensation for Study Participation
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
Time frame: 1 month