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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04908631
Recruitment Status : Enrolling by invitation
First Posted : June 1, 2021
Last Update Posted : June 3, 2022
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Transcranial Direct Stimulation Other: Auditory Training Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety and Feasibility of Transcranial Direct Current Stimulation to Enhance Auditory Rehabilitation in Cochlear Implant Recipients
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
tDCS during auditory training
Use of tDCS during completion of the auditory training program
Device: 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.
Other Name: tDCS 1x1 tES mini-CT, developed by Soterix Medical, USA

Other: 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.




Primary Outcome Measures :
  1. 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.

  2. Number of subjects who completed tDCS training [ Time Frame: 7 months ]
    Measured by total number of subjects enrolled who completed tDCS during auditory training

  3. Number subjects who demonstrated competence of tDCS training [ Time Frame: 1 month ]
    measured by provider observation during in-office and tele-visits

  4. Number of patients who reported ease of carrying out the protocol [ Time Frame: 6 months ]
    measured by survey completion

  5. Number of patients who reported difficulty of carrying out the protocol [ Time Frame: 6 months ]
    measured by survey completion

  6. Number of subjects who reported an adverse event [ Time Frame: 30 days ]
    measured by daily dairy survey completion

  7. Number of subjects who experienced skin irritation from use of tDCS [ Time Frame: 6 months ]
    measured by provider visual exam of scalp

  8. Number of subjects who experienced abnormal function of cochlear implant device [ Time Frame: 6 months ]
    measured by provider visual exam

  9. Change in speech perception performance [ Time Frame: baseline, 1 month, 6 month ]
    Measured by word and sentence lists presented in quiet (AzBio Quiet)

  10. 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)

  11. Change in communication function [ Time Frame: Baseline, 1 month, 6 month ]
    Measured by Speech, Spatial and Qualities of Hearing (SSQ12) questionnaire

  12. Change in communication function [ Time Frame: Baseline, 1 month, 6 month ]
    Measured by Cochlear Implant Quality of Life-35 Profile (CIQOL35) questionnaire


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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% 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04908631


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Howard Francis, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04908631    
Other Study ID Numbers: Pro00107525
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
Cochlear Implant
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases