Back to resultsSafety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients
Primary Purpose
Hearing Loss
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Stimulation
Auditory Training Program
Sponsored by
About this trial
This is an interventional supportive care trial for Hearing Loss focused on measuring Cochlear Implant
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% 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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
tDCS during auditory training
Arm Description
Use of tDCS during completion of the auditory training program
Outcomes
Primary Outcome Measures
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.
Number of subjects who completed tDCS training
Measured by total number of subjects enrolled who completed tDCS during auditory training
Number subjects who demonstrated competence of tDCS training
measured by provider observation during in-office and tele-visits
Number of patients who reported ease of carrying out the protocol
measured by survey completion
Number of patients who reported difficulty of carrying out the protocol
measured by survey completion
Number of subjects who reported an adverse event
measured by daily dairy survey completion
Number of subjects who experienced skin irritation from use of tDCS
measured by provider visual exam of scalp
Number of subjects who experienced abnormal function of cochlear implant device
measured by provider visual exam
Change in speech perception performance
Measured by word and sentence lists presented in quiet (AzBio Quiet)
Change in speech perception performance
Measured by word and sentence lists presented in noise (AzBio +5/+10dB; CNC 50-item list)
Change in communication function
Measured by Speech, Spatial and Qualities of Hearing (SSQ12) questionnaire
Change in communication function
Measured by Cochlear Implant Quality of Life-35 Profile (CIQOL35) questionnaire
Secondary Outcome Measures
Number of participants who reported ease of completing the training program
Measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
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
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
Number of participants who reported improvement in hearing performance
Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Number of participants who would recommend the training program
Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04908631
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Cochlear Implant
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS during auditory training
Arm Type
Other
Arm Description
Use of tDCS during completion of the auditory training program
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Stimulation
Other Intervention Name(s)
tDCS 1x1 tES mini-CT, developed by Soterix Medical, USA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Auditory Training Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number eligible patients who expressed interest in the study
Description
Measured by number of eligible patients enrolled compared to number of eligible patients who declined participation.
Time Frame
6 months
Title
Number of subjects who completed tDCS training
Description
Measured by total number of subjects enrolled who completed tDCS during auditory training
Time Frame
7 months
Title
Number subjects who demonstrated competence of tDCS training
Description
measured by provider observation during in-office and tele-visits
Time Frame
1 month
Title
Number of patients who reported ease of carrying out the protocol
Description
measured by survey completion
Time Frame
6 months
Title
Number of patients who reported difficulty of carrying out the protocol
Description
measured by survey completion
Time Frame
6 months
Title
Number of subjects who reported an adverse event
Description
measured by daily dairy survey completion
Time Frame
30 days
Title
Number of subjects who experienced skin irritation from use of tDCS
Description
measured by provider visual exam of scalp
Time Frame
6 months
Title
Number of subjects who experienced abnormal function of cochlear implant device
Description
measured by provider visual exam
Time Frame
6 months
Title
Change in speech perception performance
Description
Measured by word and sentence lists presented in quiet (AzBio Quiet)
Time Frame
baseline, 1 month, 6 month
Title
Change in speech perception performance
Description
Measured by word and sentence lists presented in noise (AzBio +5/+10dB; CNC 50-item list)
Time Frame
Baseline, 1 month, 6 month
Title
Change in communication function
Description
Measured by Speech, Spatial and Qualities of Hearing (SSQ12) questionnaire
Time Frame
Baseline, 1 month, 6 month
Title
Change in communication function
Description
Measured by Cochlear Implant Quality of Life-35 Profile (CIQOL35) questionnaire
Time Frame
Baseline, 1 month, 6 month
Secondary Outcome Measure Information:
Title
Number of participants who reported ease of completing the training program
Description
Measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Time Frame
1 month
Title
Number of participants who enjoyed doing the listening exercises on the computer
Description
Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Time Frame
1 month
Title
Number of participants who reported use of the stimulation device to be acceptable
Description
Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Time Frame
1 month
Title
Number of participants who reported improvement in hearing performance
Description
Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Time Frame
1 month
Title
Number of participants who would recommend the training program
Description
Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Time Frame
1 month
Title
Number of participants who reported acceptable compensation for study participation
Description
Measured by patient reported questionnaire, where 1 equals strongly disagree and 5 equals strongly agree
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Francis, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients
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