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

• ClinicalTrials.gov Identifier: NCT04908631
• Recruitment Status: Enrolling by invitation
• First Posted: June 1, 2021
• Last Update Posted: June 3, 2022
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Investigators

• Principal Investigator: Howard Francis, MD; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04908631
• Other Study ID Numbers: Pro00107525
• First Posted: June 1, 2021
• Last Update Posted: June 3, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases