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

Study Overview
=================
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.

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.

Official Title
-----------------
Safety and Feasibility of Transcranial Direct Current Stimulation to Enhance Auditory Rehabilitation in Cochlear Implant Recipients

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: Transcranial Direct Stimulation
* Other: Auditory Training Program


Participation Criteria
=================
Eligibility 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% 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: tDCS during auditory training<br>Use of tDCS during completion of the auditory training program | Device: Transcranial Direct Stimulation<br>* 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.<br>* Other names: tDCS 1x1 tES mini-CT, developed by Soterix Medical, USA;Other: Auditory Training Program<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number eligible patients who expressed interest in the study | 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 | Measured by total number of subjects enrolled who completed tDCS during auditory training | 7 months | 
| Number subjects who demonstrated competence of tDCS training | measured by provider observation during in-office and tele-visits | 1 month | 
| Number of patients who reported ease of carrying out the protocol | measured by survey completion | 6 months | 
| Number of patients who reported difficulty of carrying out the protocol | measured by survey completion | 6 months | 
| Number of subjects who reported an adverse event | measured by daily dairy survey completion | 30 days | 
| Number of subjects who experienced skin irritation from use of tDCS | measured by provider visual exam of scalp | 6 months | 
| Number of subjects who experienced abnormal function of cochlear implant device | measured by provider visual exam | 6 months | 
| Change in speech perception performance | Measured by word and sentence lists presented in quiet (AzBio Quiet) | baseline, 1 month, 6 month | 
| Change in speech perception performance | 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 | Measured by Speech, Spatial and Qualities of Hearing (SSQ12) questionnaire | Baseline, 1 month, 6 month | 
| Change in communication function | 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 | 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 | 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 | 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 | 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 | 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 | Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cochlear Implant