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

NCT04908631 | Completed Results FDA Device

• 1 other identifier: Pro00107525
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

Cochlear Implant

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (5)

• Number of Participants Who Enjoyed Doing the Listening Exercises on the Computer

  1 month

• Number of Participants Who Reported Use of the Stimulation Device to be Acceptable

  1 month

• Number of Participants Who Reported Improvement in Hearing Performance

  1 month

• Number of Participants Who Would Recommend the Training Program

  1 month

• Number of Participants Who Reported Acceptable Compensation for Study Participation

  1 month

Study Arms (1)

tDCS during auditory training

OTHER

Use of tDCS during completion of the auditory training program

Device: Transcranial Direct Stimulation; Other: Auditory Training Program

Interventions

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.

Also known as: tDCS 1x1 tES mini-CT, developed by Soterix Medical, USA

tDCS during auditory training

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.

tDCS during auditory training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Howard W. Francis, MD
• Organization: Duke University

howard.francis@duke.edu

919-681-8069

Study Officials

• Howard Francis, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 1, 2021
• Study Start: March 15, 2023
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)