- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04908631
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: tDCS during auditory training
Use of tDCS during completion of the auditory training program
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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:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number eligible patients who expressed interest in the study
Time Frame: 6 months
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Measured by number of eligible patients enrolled compared to number of eligible patients who declined participation.
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6 months
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Number of subjects who completed tDCS training
Time Frame: 7 months
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Measured by total number of subjects enrolled who completed tDCS during auditory training
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7 months
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Number subjects who demonstrated competence of tDCS training
Time Frame: 1 month
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measured by provider observation during in-office and tele-visits
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1 month
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Number of patients who reported ease of carrying out the protocol
Time Frame: 6 months
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measured by survey completion
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6 months
|
Number of patients who reported difficulty of carrying out the protocol
Time Frame: 6 months
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measured by survey completion
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6 months
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Number of subjects who reported an adverse event
Time Frame: 30 days
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measured by daily dairy survey completion
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30 days
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Number of subjects who experienced skin irritation from use of tDCS
Time Frame: 6 months
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measured by provider visual exam of scalp
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6 months
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Number of subjects who experienced abnormal function of cochlear implant device
Time Frame: 6 months
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measured by provider visual exam
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6 months
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Change in speech perception performance
Time Frame: baseline, 1 month, 6 month
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Measured by word and sentence lists presented in quiet (AzBio Quiet)
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baseline, 1 month, 6 month
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Change in speech perception performance
Time Frame: Baseline, 1 month, 6 month
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Measured by word and sentence lists presented in noise (AzBio +5/+10dB; CNC 50-item list)
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Baseline, 1 month, 6 month
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Change in communication function
Time Frame: Baseline, 1 month, 6 month
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Measured by Speech, Spatial and Qualities of Hearing (SSQ12) questionnaire
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Baseline, 1 month, 6 month
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Change in communication function
Time Frame: Baseline, 1 month, 6 month
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Measured by Cochlear Implant Quality of Life-35 Profile (CIQOL35) questionnaire
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Baseline, 1 month, 6 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who reported ease of completing the training program
Time Frame: 1 month
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Measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
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1 month
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Number of participants who enjoyed doing the listening exercises on the computer
Time Frame: 1 month
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Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
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1 month
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Number of participants who reported use of the stimulation device to be acceptable
Time Frame: 1 month
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Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
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1 month
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Number of participants who reported improvement in hearing performance
Time Frame: 1 month
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Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
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1 month
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Number of participants who would recommend the training program
Time Frame: 1 month
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Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
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1 month
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Number of participants who reported acceptable compensation for study participation
Time Frame: 1 month
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Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Howard Francis, MD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00107525
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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