Hearing LossNCT04908631
Safety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients
A study testing Transcranial Direct Stimulation and Auditory Training Program in people with Hearing Loss, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Transcranial Direct Stimulation and Auditory Training Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Safety and Feasibility of Transcranial Direct Current Stimulation to Enhance Auditory Rehabilitation in Cochlear Implant Recipients
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Transcranial Direct Stimulation, Auditory Training Program
- Keywords
- Cochlear Implant
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct StimulationDevice
Also called tDCS 1x1 tES mini-CT, developed by Soterix Medical, USA
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 ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS during auditory training | Other | Use of tDCS during completion of the auditory training program Receives: Device: Transcranial Direct Stimulation; Other: Auditory Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Eligible Patients Who Expressed Interest in the Study
Measured: 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
Measured: up to 7 months
Number of Participants Who Demonstrated Competence of tDCS Training
Measured by provider observation during in-office and tele-visits
Measured: 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.
Measured: 1 month
Number of Participants Who Reported an Adverse Event
Measured by daily diary survey completion.
Measured: 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.
Measured: 6 months
Number of Subjects Who Experienced Abnormal Function of Cochlear Implant Device
Measured by telemetry assessment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start15 Mar 2023
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Francis, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908631
- Sponsor's protocol ID
- Pro00107525
- Status last verified
- Aug 2025
- First submitted
- 21 May 2021
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Transcranial Direct Current Stimulation to Enhance Auditory Rehabilitation in Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT04908631
- Acronym / sponsor ID
- Pro00107525
- Conditions
- Hearing Loss
- Keywords
- Cochlear Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tDCS during auditory training | Other | Device: Transcranial Direct Stimulation, Other: Auditory Training ProgramUse of tDCS during completion of the auditory training program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct StimulationAlso: tDCS 1x1 tES mini-CT, developed by Soterix Medical, USABrain 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. | Device | tDCS during auditory training |
| Auditory Training ProgramWeb-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. | Other | tDCS during auditory training |
Primary outcome
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
Time frame: 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
Time frame: 1 month
Measured by provider observation during in-office and tele-visits
Number of Participants Who Reported Ease of Completing the Training Program
Time frame: 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
Time frame: 30 days
Measured by daily diary survey completion.
Number of Participants Who Experienced Skin Irritation From Use of tDCS
Time frame: 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
Time frame: 6 months
Measured by telemetry assessment.
Speech Perception Performance - Sentence Recognition in Quiet
Time frame: 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
Time frame: 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
Time frame: 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.
Cochlear Implant Quality of Life-35 Profile (CIQOL35) Questionnaire
Time frame: 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.
5 secondary outcomes
Number of Participants Who Enjoyed Doing the Listening Exercises on the Computer
Time frame: 1 month
Number of Participants Who Reported Use of the Stimulation Device to be Acceptable
Time frame: 1 month
Number of Participants Who Reported Improvement in Hearing Performance
Time frame: 1 month
Number of Participants Who Would Recommend the Training Program
Time frame: 1 month
Number of Participants Who Reported Acceptable Compensation for Study Participation
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Francis, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Stimulation and Auditory Training Program in people with Hearing Loss, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Eligible Patients Who Expressed Interest in the Study (time frame: During the screening period of approximately 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.