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

Duke University

Status

Completed

Conditions

Hearing Loss

Treatments

Device: Transcranial Direct Stimulation

Other: Auditory Training Program

Study type

Interventional

Funder types

Other

Identifiers

NCT04908631

Pro00107525

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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