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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04908631
• Other study ID #: Pro00107525
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of subjects who completed tDCS training	Measured by total number of subjects enrolled who completed tDCS during auditory training	7 months
Primary	Number subjects who demonstrated competence of tDCS training	measured by provider observation during in-office and tele-visits	1 month
Primary	Number of patients who reported ease of carrying out the protocol	measured by survey completion	6 months
Primary	Number of patients who reported difficulty of carrying out the protocol	measured by survey completion	6 months
Primary	Number of subjects who reported an adverse event	measured by daily dairy survey completion	30 days
Primary	Number of subjects who experienced skin irritation from use of tDCS	measured by provider visual exam of scalp	6 months
Primary	Number of subjects who experienced abnormal function of cochlear implant device	measured by provider visual exam	6 months
Primary	Change in speech perception performance	Measured by word and sentence lists presented in quiet (AzBio Quiet)	baseline, 1 month, 6 month
Primary	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
Primary	Change in communication function	Measured by Speech, Spatial and Qualities of Hearing (SSQ12) questionnaire	Baseline, 1 month, 6 month
Primary	Change in communication function	Measured by Cochlear Implant Quality of Life-35 Profile (CIQOL35) questionnaire	Baseline, 1 month, 6 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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