Trial Outcomes & Findings for Safety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients (NCT NCT04908631)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

During the screening period of approximately 6 months

Results posted on

2025-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	tDCS During Auditory Training Use of tDCS during completion of the auditory training program 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. 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.
Overall Study STARTED	8
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	tDCS During Auditory Training Use of tDCS during completion of the auditory training program 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. 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.
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	1
Overall Study Received a second implant after the 1 month visit	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	tDCS During Auditory Training n=8 Participants Use of tDCS during completion of the auditory training program 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. 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.
Age, Continuous	63.9 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the screening period of approximately 6 months

Population: Eligible patients who expressed interest in the study.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=61 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number Eligible Patients Who Expressed Interest in the Study	61 Participants

PRIMARY outcome

Timeframe: up to 7 months

Measured by total number of subjects enrolled who completed tDCS during auditory training

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=8 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number of Subjects Who Completed tDCS Training	6 Participants

PRIMARY outcome

Timeframe: 1 month

Population: One participant withdrew before the baseline visit.

Measured by provider observation during in-office and tele-visits

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=7 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number of Participants Who Demonstrated Competence of tDCS Training	7 Participants

PRIMARY outcome

Timeframe: 1 month

Population: One participant withdrew before the baseline visit. One participant did not complete the training.

Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=6 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number of Participants Who Reported Ease of Completing the Training Program	6 Participants

PRIMARY outcome

Timeframe: 30 days

Population: One participant withdrew before the baseline visit. One participant did not complete the daily diary.

Measured by daily diary survey completion.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=6 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number of Participants Who Reported an Adverse Event	0 Participants

PRIMARY outcome

Timeframe: 6 months

Population: One participant withdrew before the baseline visit.

Measured by provider visual exam of scalp. Skin tingling/warmth is a known side effect of stimulation.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=7 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number of Participants Who Experienced Skin Irritation From Use of tDCS	6 Participants

PRIMARY outcome

Timeframe: 6 months

Population: One participant withdrew prior to the baseline visit.

Measured by telemetry assessment.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=7 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number of Subjects Who Experienced Abnormal Function of Cochlear Implant Device	0 Participants

PRIMARY outcome

Timeframe: Baseline, 1 month, 6 month

Population: Seven participants had a baseline assessment. One withdrew prior to 1 month; one additional participant withdrew prior to 6 months.

Measured by word and sentence lists presented in quiet (AzBio Quiet). Average of two AzBio lists presented in quiet. Range of scores is from 0-100, with higher scores indicating higher speech perception performance.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=7 Participants Use of tDCS during completion of the auditory training program 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. 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.
Speech Perception Performance - Sentence Recognition in Quiet Baseline	59.6 score on a scale Standard Deviation 33.1
Speech Perception Performance - Sentence Recognition in Quiet 1 Month	68.8 score on a scale Standard Deviation 23.1
Speech Perception Performance - Sentence Recognition in Quiet 6 Months	67.4 score on a scale Standard Deviation 25.4

PRIMARY outcome

Timeframe: Baseline, 1 month, 6 month

Population: Seven participants had a baseline assessment. One withdrew prior to 1 month; one additional participant withdrew prior to 6 months.

Measured by 50-item CNC word list. CNC word lists are standardized sets of monosyllabic words used in audiology to assess speech recognition ability, particularly in cochlear implant users. Reported as a percentage (0-100%), with higher values indicating better word recognition.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=7 Participants Use of tDCS during completion of the auditory training program 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. 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.
Speech Perception Performance - Word Recognition Performance Baseline	43.1 percentage of words Standard Deviation 22.1
Speech Perception Performance - Word Recognition Performance 1 Month	55.3 percentage of words Standard Deviation 21.9
Speech Perception Performance - Word Recognition Performance 6 Months	47.2 percentage of words Standard Deviation 10.3

PRIMARY outcome

Timeframe: Baseline, 1 month, 6 months

Population: One participant withdrew prior to 1 month; one additional participant withdrew prior to 6 months.

The SSQ12 questionnaire is scored as a mean of the 12 items, with a range of 0 to 10. A higher score indicates greater communication function.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=7 Participants Use of tDCS during completion of the auditory training program 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. 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.
Communication Function as Measured by Speech, Spatial and Qualities of Hearing (SSQ12) Questionnaire 1 month	4.5 score on a scale Standard Deviation 1.6
Communication Function as Measured by Speech, Spatial and Qualities of Hearing (SSQ12) Questionnaire Baseline	3.6 score on a scale Standard Deviation 1.9
Communication Function as Measured by Speech, Spatial and Qualities of Hearing (SSQ12) Questionnaire 6 months	4.5 score on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: Baseline, 1 month, 6 months

Population: One participant withdrew prior to 1 month; one additional participant withdrew prior to 6 months.

The CIQOL35 raw score is calculated by summing the items for each domain. In this case, the raw score for the Global 10 domain is reported. The range in raw scores is 10-50, where a higher score indicates great quality of life.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=7 Participants Use of tDCS during completion of the auditory training program 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. 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.
Cochlear Implant Quality of Life-35 Profile (CIQOL35) Questionnaire Baseline	32.9 score on a scale Standard Deviation 4.7
Cochlear Implant Quality of Life-35 Profile (CIQOL35) Questionnaire 1 month	36.0 score on a scale Standard Deviation 6.1
Cochlear Implant Quality of Life-35 Profile (CIQOL35) Questionnaire 6 months	36.8 score on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: 1 month

Population: One participant withdrew before the baseline visit. One participant did not complete the training.

Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=6 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number of Participants Who Enjoyed Doing the Listening Exercises on the Computer	6 Participants

SECONDARY outcome

Timeframe: 1 month

Population: One participant withdrew before the baseline visit. One participant did not complete the training.

Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=6 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number of Participants Who Reported Use of the Stimulation Device to be Acceptable	4 Participants

SECONDARY outcome

Timeframe: 1 month

Population: One participant withdrew before the baseline visit. One participant did not complete the training.

Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=6 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number of Participants Who Reported Improvement in Hearing Performance	5 Participants

SECONDARY outcome

Timeframe: 1 month

Population: One participant withdrew before the baseline visit. One participant did not complete the training.

Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=6 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number of Participants Who Would Recommend the Training Program	4 Participants

SECONDARY outcome

Timeframe: 1 month

Population: One participant withdrew before the baseline visit. One participant did not complete the training.

Number of participants who reported agree or strongly agree as measured by questionnaire, where 1 equals strongly disagree and 5 equals strongly agree.

Outcome measures

Outcome measures
Measure	tDCS During Auditory Training n=6 Participants Use of tDCS during completion of the auditory training program 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. 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.
Number of Participants Who Reported Acceptable Compensation for Study Participation	6 Participants

Adverse Events

tDCS During Auditory Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Howard W. Francis, MD

Duke University

Phone: 919-681-8069

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place