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

Not Applicable

Active, not recruiting

Interventions: Device: Transcranial Direct Stimulation
Other: Auditory Training Program

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
tDCS during auditory training	Auditory Training Program	Use of tDCS during completion of the auditory training program
tDCS during auditory training	Transcranial Direct Stimulation	Use of tDCS during completion of the auditory training program

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants who reported acceptable compensation for study participation	1 month	Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Number of participants who reported ease of completing the training program	1 month	Measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Number of participants who reported use of the stimulation device to be acceptable	1 month	Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Number of participants who enjoyed doing the listening exercises on the computer	1 month	Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Number of participants who would recommend the training program	1 month	Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Number of participants who reported improvement in hearing performance	1 month	Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree

Locations (1): Duke University Medical Center
🇺🇸
Durham, North Carolina, United States