Hearing Loss
Conditions
Keywords
Cochlear Implant
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cochlear Implant Quality of Life-35 Profile (CIQOL35) Questionnaire | 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. |
| Number of Participants Who Experienced Skin Irritation From Use of tDCS | 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 | 6 months | Measured by telemetry assessment. |
| Speech Perception Performance - Sentence Recognition in Quiet | 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 | 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. |
| Communication Function as Measured by Speech, Spatial and Qualities of Hearing (SSQ12) Questionnaire | 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. |
| Number Eligible Patients Who Expressed Interest in the Study | During the screening period of approximately 6 months | — |
| Number of Subjects Who Completed tDCS Training | 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 | 1 month | Measured by provider observation during in-office and tele-visits |
| Number of Participants Who Reported Ease of Completing the Training Program | 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 | 30 days | Measured by daily diary survey completion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Use of the Stimulation Device to be Acceptable | 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 Improvement in Hearing Performance | 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 Would Recommend the Training Program | 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 Acceptable Compensation for Study Participation | 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 Enjoyed Doing the Listening Exercises on the Computer | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Received a second implant after the 1 month visit | 1 |
Baseline characteristics
| Characteristic | tDCS During Auditory Training |
|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 15.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
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.
Time frame: Baseline, 1 month, 6 months
Population: One participant withdrew prior to 1 month; one additional participant withdrew prior to 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tDCS During Auditory Training | Cochlear Implant Quality of Life-35 Profile (CIQOL35) Questionnaire | 6 months | 36.8 score on a scale | Standard Deviation 5.4 |
| tDCS During Auditory Training | Cochlear Implant Quality of Life-35 Profile (CIQOL35) Questionnaire | Baseline | 32.9 score on a scale | Standard Deviation 4.7 |
| tDCS During Auditory Training | Cochlear Implant Quality of Life-35 Profile (CIQOL35) Questionnaire | 1 month | 36.0 score on a scale | Standard Deviation 6.1 |
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.
Time frame: Baseline, 1 month, 6 months
Population: One participant withdrew prior to 1 month; one additional participant withdrew prior to 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tDCS During Auditory Training | Communication Function as Measured by Speech, Spatial and Qualities of Hearing (SSQ12) Questionnaire | Baseline | 3.6 score on a scale | Standard Deviation 1.9 |
| tDCS During Auditory Training | Communication Function as Measured by Speech, Spatial and Qualities of Hearing (SSQ12) Questionnaire | 1 month | 4.5 score on a scale | Standard Deviation 1.6 |
| tDCS During Auditory Training | Communication Function as Measured by Speech, Spatial and Qualities of Hearing (SSQ12) Questionnaire | 6 months | 4.5 score on a scale | Standard Deviation 2.1 |
Primary
Number Eligible Patients Who Expressed Interest in the Study
Time frame: During the screening period of approximately 6 months
Population: Eligible patients who expressed interest in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number Eligible Patients Who Expressed Interest in the Study | 61 Participants |
Primary
Number of Participants Who Demonstrated Competence of tDCS Training
Measured by provider observation during in-office and tele-visits
Time frame: 1 month
Population: One participant withdrew before the baseline visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number of Participants Who Demonstrated Competence of tDCS Training | 7 Participants |
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.
Time frame: 6 months
Population: One participant withdrew before the baseline visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number of Participants Who Experienced Skin Irritation From Use of tDCS | 6 Participants |
Primary
Number of Participants Who Reported an Adverse Event
Measured by daily diary survey completion.
Time frame: 30 days
Population: One participant withdrew before the baseline visit. One participant did not complete the daily diary.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number of Participants Who Reported an Adverse Event | 0 Participants |
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.
Time frame: 1 month
Population: One participant withdrew before the baseline visit. One participant did not complete the training.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number of Participants Who Reported Ease of Completing the Training Program | 6 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number of Subjects Who Completed tDCS Training | 6 Participants |
Primary
Number of Subjects Who Experienced Abnormal Function of Cochlear Implant Device
Measured by telemetry assessment.
Time frame: 6 months
Population: One participant withdrew prior to the baseline visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number of Subjects Who Experienced Abnormal Function of Cochlear Implant Device | 0 Participants |
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.
Time frame: Baseline, 1 month, 6 month
Population: Seven participants had a baseline assessment. One withdrew prior to 1 month; one additional participant withdrew prior to 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tDCS During Auditory Training | Speech Perception Performance - Sentence Recognition in Quiet | Baseline | 59.6 score on a scale | Standard Deviation 33.1 |
| tDCS During Auditory Training | Speech Perception Performance - Sentence Recognition in Quiet | 1 Month | 68.8 score on a scale | Standard Deviation 23.1 |
| tDCS During Auditory Training | Speech Perception Performance - Sentence Recognition in Quiet | 6 Months | 67.4 score on a scale | Standard Deviation 25.4 |
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.
Time frame: Baseline, 1 month, 6 month
Population: Seven participants had a baseline assessment. One withdrew prior to 1 month; one additional participant withdrew prior to 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tDCS During Auditory Training | Speech Perception Performance - Word Recognition Performance | Baseline | 43.1 percentage of words | Standard Deviation 22.1 |
| tDCS During Auditory Training | Speech Perception Performance - Word Recognition Performance | 1 Month | 55.3 percentage of words | Standard Deviation 21.9 |
| tDCS During Auditory Training | Speech Perception Performance - Word Recognition Performance | 6 Months | 47.2 percentage of words | Standard Deviation 10.3 |
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.
Time frame: 1 month
Population: One participant withdrew before the baseline visit. One participant did not complete the training.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number of Participants Who Enjoyed Doing the Listening Exercises on the Computer | 6 Participants |
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.
Time frame: 1 month
Population: One participant withdrew before the baseline visit. One participant did not complete the training.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number of Participants Who Reported Acceptable Compensation for Study Participation | 6 Participants |
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.
Time frame: 1 month
Population: One participant withdrew before the baseline visit. One participant did not complete the training.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number of Participants Who Reported Improvement in Hearing Performance | 5 Participants |
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.
Time frame: 1 month
Population: One participant withdrew before the baseline visit. One participant did not complete the training.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number of Participants Who Reported Use of the Stimulation Device to be Acceptable | 4 Participants |
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.
Time frame: 1 month
Population: One participant withdrew before the baseline visit. One participant did not complete the training.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tDCS During Auditory Training | Number of Participants Who Would Recommend the Training Program | 4 Participants |