An interventional study of Transcranial Direct Stimulation and Auditory Training Program in Hearing Loss, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use of tDCS during completion of the auditory training program
Device: Transcranial Direct Stimulation · Other: Auditory Training Program
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.
Also known as: tDCS 1x1 tES mini-CT, developed by Soterix Medical, USA
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.
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.
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
| Milestone | tDCS During Auditory Training |
|---|---|
| Started | 8 |
| Completed | 5 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Received a second implant after the 1 month visit | 1 |
| Participants | tDCS During Auditory Training |
|---|---|
| Number Eligible Patients Who Expressed Interest in the Study | 61 |
Measured by total number of subjects enrolled who completed tDCS during auditory training
| Participants | tDCS During Auditory Training |
|---|---|
| Number of Subjects Who Completed tDCS Training | 6 |
Measured by provider observation during in-office and tele-visits
| Participants | tDCS During Auditory Training |
|---|---|
| Number of Participants Who Demonstrated Competence of tDCS Training | 7 |
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
| Participants | tDCS During Auditory Training |
|---|---|
| Number of Participants Who Reported Ease of Completing the Training Program | 6 |
Measured by daily diary survey completion.
| Participants | tDCS During Auditory Training |
|---|---|
| Number of Participants Who Reported an Adverse Event | 0 |
Measured by provider visual exam of scalp. Skin tingling/warmth is a known side effect of stimulation.
| Participants | tDCS During Auditory Training |
|---|---|
| Number of Participants Who Experienced Skin Irritation From Use of tDCS | 6 |
Measured by telemetry assessment.
| Participants | tDCS During Auditory Training |
|---|---|
| Number of Subjects Who Experienced Abnormal Function of Cochlear Implant Device | 0 |
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.
| score on a scale | tDCS During Auditory Training |
|---|---|
| Baseline | 59.6 ± 33.1 |
| 1 Month | 68.8 ± 23.1 |
| 6 Months | 67.4 ± 25.4 |
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.
| percentage of words | tDCS During Auditory Training |
|---|---|
| Baseline | 43.1 ± 22.1 |
| 1 Month | 55.3 ± 21.9 |
| 6 Months | 47.2 ± 10.3 |
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.
| score on a scale | tDCS During Auditory Training |
|---|---|
| Baseline | 3.6 ± 1.9 |
| 1 month | 4.5 ± 1.6 |
| 6 months | 4.5 ± 2.1 |
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.
| score on a scale | tDCS During Auditory Training |
|---|---|
| Baseline | 32.9 ± 4.7 |
| 1 month | 36.0 ± 6.1 |
| 6 months | 36.8 ± 5.4 |
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
| Participants | tDCS During Auditory Training |
|---|---|
| Number of Participants Who Enjoyed Doing the Listening Exercises on the Computer | 6 |
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
| Participants | tDCS During Auditory Training |
|---|---|
| Number of Participants Who Reported Use of the Stimulation Device to be Acceptable | 4 |
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
| Participants | tDCS During Auditory Training |
|---|---|
| Number of Participants Who Reported Improvement in Hearing Performance | 5 |
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
| Participants | tDCS During Auditory Training |
|---|---|
| Number of Participants Who Would Recommend the Training Program | 4 |
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.
| Participants | tDCS During Auditory Training |
|---|---|
| Number of Participants Who Reported Acceptable Compensation for Study Participation | 6 |
Collected over From the start of auditory training with tDCS at week 2 until the six-month follow-up visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| tDCS During Auditory Training | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | tDCS During Auditory Training |
|---|---|
| Mean | 63.9 ± 15.6 |
| Sex: Female, Male(Participants) | tDCS During Auditory Training |
|---|---|
| Female | 3 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | tDCS During Auditory Training |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | tDCS During Auditory Training |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | tDCS During Auditory Training |
|---|---|
| United States | 8 |
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