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Completed

NCT Number: NCT04908631

Safety and Feasibility of tDCS 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: tDCS 1x1 tES mini-CT, developed by Soterix Medical, USA

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.

Primary outcomes

  1. Number Eligible Patients Who Expressed Interest in the Study

    Time frame: During the screening period of approximately 6 months

  2. 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

  3. Number of Participants Who Demonstrated Competence of tDCS Training

    Time frame: 1 month

    Measured by provider observation during in-office and tele-visits

  4. 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.

  5. Number of Participants Who Reported an Adverse Event

    Time frame: 30 days

    Measured by daily diary survey completion.

  6. 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.

  7. Number of Subjects Who Experienced Abnormal Function of Cochlear Implant Device

    Time frame: 6 months

    Measured by telemetry assessment.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Secondary outcomes

  1. Number of Participants Who Enjoyed Doing the Listening Exercises on the Computer

    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.

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

    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.

  3. Number of Participants Who Reported Improvement in Hearing Performance

    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.

  4. Number of Participants Who Would Recommend 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.

  5. Number of Participants Who Reported Acceptable Compensation for Study Participation

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Safety and Feasibility of Transcranial Direct Current Stimulation to Enhance Auditory Rehabilitation in Cochlear Implant Recipients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2021
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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