Safety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Transcranial Direct Stimulation; Other: Auditory Training Program

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: tDCS during auditory training; Use of tDCS during completion of the auditory training program

Device: 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.; Other Names: tDCS 1x1 tES mini-CT, developed by Soterix Medical, USA; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Howard Francis, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): July 29, 2024
• Study Completion (Actual): July 29, 2024

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cochlear Implant
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: Pro00107525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No