N/A
N=8
Safety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT04908631 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Number Eligible Patients Who Expressed Interest in the Study — 61 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Direct Stimulation (Device); Auditory Training Program (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Eligible Patients Who Expressed Interest in the Study |
61 | — |
| PRIMARY Number of Subjects Who Completed tDCS Training |
6 | — |
| PRIMARY Number of Participants Who Demonstrated Competence of tDCS Training |
7 | — |
| PRIMARY Number of Participants Who Reported Ease of Completing the Training Program |
6 | — |
| PRIMARY Number of Participants Who Reported an Adverse Event |
— | — |
| PRIMARY Number of Participants Who Experienced Skin Irritation From Use of tDCS |
6 | — |
| PRIMARY Number of Subjects Who Experienced Abnormal Function of Cochlear Implant Device |
— | — |
| PRIMARY Speech Perception Performance - Sentence Recognition in Quiet |
59.6; 68.8; 67.4 | — |
| PRIMARY Speech Perception Performance - Word Recognition Performance |
43.1; 55.3; 47.2 | — |
| PRIMARY Communication Function as Measured by Speech, Spatial and Qualities of Hearing (SSQ12) Questionnaire |
3.6; 4.5; 4.5 | — |
| PRIMARY Cochlear Implant Quality of Life-35 Profile (CIQOL35) Questionnaire |
32.9; 36.0; 36.8 | — |
| SECONDARY Number of Participants Who Enjoyed Doing the Listening Exercises on the Computer |
6 | — |
| SECONDARY Number of Participants Who Reported Use of the Stimulation Device to be Acceptable |
4 | — |
| SECONDARY Number of Participants Who Reported Improvement in Hearing Performance |
5 | — |
| SECONDARY Number of Participants Who Would Recommend the Training Program |
4 | — |
| SECONDARY Number of Participants Who Reported Acceptable Compensation for Study Participation |
6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04908631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.