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

November 14, 2023 updated by: Duke University

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

Enrolling by invitation

Conditions

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 (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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
Time Frame: 6 months
Measured by number of eligible patients enrolled compared to number of eligible patients who declined participation.
6 months
Number of subjects who completed tDCS training
Time Frame: 7 months
Measured by total number of subjects enrolled who completed tDCS during auditory training
7 months
Number subjects who demonstrated competence of tDCS training
Time Frame: 1 month
measured by provider observation during in-office and tele-visits
1 month
Number of patients who reported ease of carrying out the protocol
Time Frame: 6 months
measured by survey completion
6 months
Number of patients who reported difficulty of carrying out the protocol
Time Frame: 6 months
measured by survey completion
6 months
Number of subjects who reported an adverse event
Time Frame: 30 days
measured by daily dairy survey completion
30 days
Number of subjects who experienced skin irritation from use of tDCS
Time Frame: 6 months
measured by provider visual exam of scalp
6 months
Number of subjects who experienced abnormal function of cochlear implant device
Time Frame: 6 months
measured by provider visual exam
6 months
Change in speech perception performance
Time Frame: baseline, 1 month, 6 month
Measured by word and sentence lists presented in quiet (AzBio Quiet)
baseline, 1 month, 6 month
Change in speech perception performance
Time Frame: Baseline, 1 month, 6 month
Measured by word and sentence lists presented in noise (AzBio +5/+10dB; CNC 50-item list)
Baseline, 1 month, 6 month
Change in communication function
Time Frame: Baseline, 1 month, 6 month
Measured by Speech, Spatial and Qualities of Hearing (SSQ12) questionnaire
Baseline, 1 month, 6 month
Change in communication function
Time Frame: Baseline, 1 month, 6 month
Measured by Cochlear Implant Quality of Life-35 Profile (CIQOL35) questionnaire
Baseline, 1 month, 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who reported ease of completing the training program
Time Frame: 1 month
Measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
1 month
Number of participants who enjoyed doing the listening exercises on the computer
Time Frame: 1 month
Measured by patient reported 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
Time Frame: 1 month
Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
1 month
Number of participants who reported improvement in hearing performance
Time Frame: 1 month
Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
1 month
Number of participants who would recommend the training program
Time Frame: 1 month
Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
1 month
Number of participants who reported acceptable compensation for study participation
Time Frame: 1 month
Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Howard Francis, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 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 (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

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

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.

Clinical Trials on Hearing Loss

Clinical Trials on Transcranial Direct Stimulation

3
Subscribe