Clinical trial NCT04908631: Safety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients
Official title: Safety and Feasibility of Transcranial Direct Current Stimulation to Enhance Auditory Rehabilitation in Cochlear Implant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Cochlear Implant
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number eligible patients who expressed interest in the study
timeFrame: 6 months
measure: Number of subjects who completed tDCS training
timeFrame: 7 months
measure: Number subjects who demonstrated competence of tDCS training
timeFrame: 1 month
measure: Number of patients who reported ease of carrying out the protocol
timeFrame: 6 months
measure: Number of patients who reported difficulty of carrying out the protocol
timeFrame: 6 months
measure: Number of subjects who reported an adverse event
timeFrame: 30 days
measure: Number of subjects who experienced skin irritation from use of tDCS
timeFrame: 6 months
measure: Number of subjects who experienced abnormal function of cochlear implant device
timeFrame: 6 months
measure: Change in speech perception performance
timeFrame: baseline, 1 month, 6 month
measure: Change in speech perception performance
timeFrame: Baseline, 1 month, 6 month
measure: Change in communication function
timeFrame: Baseline, 1 month, 6 month
measure: Change in communication function
timeFrame: Baseline, 1 month, 6 month
Secondary outcomes:
measure: Number of participants who reported ease of completing the training program
timeFrame: 1 month
measure: Number of participants who enjoyed doing the listening exercises on the computer
timeFrame: 1 month
measure: Number of participants who reported use of the stimulation device to be acceptable
timeFrame: 1 month
measure: Number of participants who reported improvement in hearing performance
timeFrame: 1 month
measure: Number of participants who would recommend the training program
timeFrame: 1 month
measure: Number of participants who reported acceptable compensation for study participation
timeFrame: 1 month
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Howard Francis, MD
role: PRINCIPAL_INVESTIGATOR
References: