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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS during auditory training | Other | Use of tDCS during completion of the auditory training program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number Eligible Patients Who Expressed Interest in the Study | 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 | up to 7 months |
| Number of Participants Who Demonstrated Competence of tDCS Training | Measured by provider observation during in-office and tele-visits | 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. | 1 month |
| Number of Participants Who Reported an Adverse Event | Measured by daily diary survey completion. | 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. | 6 months |
| Number of Subjects Who Experienced Abnormal Function of Cochlear Implant Device | Measured by telemetry assessment. | 6 months |
| Speech Perception Performance - Sentence Recognition in Quiet |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Number of Participants Who Reported Use of the Stimulation Device to be Acceptable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Francis, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | tDCS During Auditory Training | Use of tDCS during completion of the auditory training program Transcranial Direct Stimulation: 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. Auditory Training Program: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | tDCS During Auditory Training | Use of tDCS during completion of the auditory training program Transcranial Direct Stimulation: 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. Auditory Training Program: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number Eligible Patients Who Expressed Interest in the Study | Eligible patients who expressed interest in the study. | Posted | Count of Participants | Participants | During the screening period of approximately 6 months |
|
From the start of auditory training with tDCS at week 2 until the six-month follow-up visit
Daily survey of known symptoms/side effects was submitted by the participant during training. One participant withdrew before the baseline visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | tDCS During Auditory Training | Use of tDCS during completion of the auditory training program Transcranial Direct Stimulation: 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. Auditory Training Program: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard W. Francis, MD | Duke University | 919-681-8069 | howard.francis@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2022 | Jul 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
|
| Auditory Training Program | Other | 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. |
|
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. |
| 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. | 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. | 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. | Baseline, 1 month, 6 months |
Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree. |
| 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. | 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. | 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. | 1 month |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Subjects Who Completed tDCS Training | Measured by total number of subjects enrolled who completed tDCS during auditory training | Posted | Count of Participants | Participants | up to 7 months |
|
|
|
| Primary | Number of Participants Who Demonstrated Competence of tDCS Training | Measured by provider observation during in-office and tele-visits | One participant withdrew before the baseline visit. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Primary | 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. | One participant withdrew before the baseline visit. One participant did not complete the training. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Primary | Number of Participants Who Reported an Adverse Event | Measured by daily diary survey completion. | One participant withdrew before the baseline visit. One participant did not complete the daily diary. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Primary | 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. | One participant withdrew before the baseline visit. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Number of Subjects Who Experienced Abnormal Function of Cochlear Implant Device | Measured by telemetry assessment. | One participant withdrew prior to the baseline visit. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | 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. | Seven participants had a baseline assessment. One withdrew prior to 1 month; one additional participant withdrew prior to 6 months. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month, 6 month |
|
|
|
| Primary | 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. | Seven participants had a baseline assessment. One withdrew prior to 1 month; one additional participant withdrew prior to 6 months. | Posted | Mean | Standard Deviation | percentage of words | Baseline, 1 month, 6 month |
|
|
|
| Primary | 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. | One participant withdrew prior to 1 month; one additional participant withdrew prior to 6 months. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month, 6 months |
|
|
|
| Primary | 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. | One participant withdrew prior to 1 month; one additional participant withdrew prior to 6 months. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month, 6 months |
|
|
|
| Secondary | 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. | One participant withdrew before the baseline visit. One participant did not complete the training. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | 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. | One participant withdrew before the baseline visit. One participant did not complete the training. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | 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. | One participant withdrew before the baseline visit. One participant did not complete the training. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | 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. | One participant withdrew before the baseline visit. One participant did not complete the training. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | 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. | One participant withdrew before the baseline visit. One participant did not complete the training. | Posted | Count of Participants | Participants | 1 month |
|
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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| 6 Months |
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| Title | Measurements |
|---|---|
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| 6 months |
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| 6 months |
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