Safety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients
NCT ID: NCT04908631
Last Updated: 2025-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2023-03-15
2024-07-29
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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tDCS during auditory training
Use of tDCS during completion of the auditory training program
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Howard Francis, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00107525
Identifier Type: -
Identifier Source: org_study_id
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