- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06738030
Transcranial Stimulation Combined With Auditory Training
The goal of this clinical trial is to learn if non-invasive brain stimulation (called transcranial stimulation) can enhance the benefits from auditory training in people who struggle to understand one talker when many people are talking at the same time. The main questions it aims to answer are:
- Does transcranial stimulation improve speech-on-speech understanding in people who struggle with this task?
- Does transcranial stimulation enhance the benefits of a commercially available auditory training program?
Researchers will compare transcranial stimulation to sham stimulation (no stimulation is applied during the listening task).
Participants will:
- Receive login information to an online auditory training program to complete at home over 2 weeks
- Visit the laboratory 4 times to receive transcranial stimulation while listening to speech-on-speech: once before at-home training, two times during the at-home training period, and once after at-home training has ended
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elin Roverud, AuD, PhD
- Phone Number: 617-358-7440
- Email: erover@bu.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Communication Neuroscience Research Lab at Boston University
-
Contact:
- Tyler Perrachione, PhD
- Phone Number: 617-358-7410
- Email: tkp@bu.edu
-
Contact:
- Monique Montoute
- Email: mmontout@bu.edu
-
Principal Investigator:
- Elin Roverud, AuD, PhD
-
Sub-Investigator:
- Tyler Perrachione, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 50 years of age or older
- Audiometric thresholds that do not exceed 90 dB HL at any frequency from 250-6000 Hz
- Able to provide informed consent and understand experimental instructions
- Able to read print on a computer screen
- Difficulty with speech-on-speech understanding
- Access to computer or mobile phone with access to internet that can play sound (for the at-home training)
Exclusion Criteria:
- Non-native speakers of English
- History of skull fracture, scalp tissue damage, metallic implants around the head, seizures, neurological disorders, or traumatic brain injury, current or suspected pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active transcranial stimulation
This group will receive active transcranial alternating current stimulation that matches the envelope of the target speech.
|
The transcranial alternating current stimulation is delivered during the speech stimulus and the current matches the envelope of the target speech
An at-home auditory training program that adaptively and interactively trains the listener in degraded speech, cognitive skills, and communication strategies
|
|
Sham Comparator: Sham stimulation
This group will receive transcranial stimulation that ramps on and off before the speech is presented.
|
An at-home auditory training program that adaptively and interactively trains the listener in degraded speech, cognitive skills, and communication strategies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech-on-speech intelligibility percent correct
Time Frame: From enrollment to the end of participation at 6 weeks
|
Percent correct score on the speech-on-speech task assessed in the lab
|
From enrollment to the end of participation at 6 weeks
|
|
Pupillometry measured listening effort
Time Frame: From enrollment to the end of participation at 6 weeks
|
The peak pupil dilation subtracted from pre-trial baseline pupil dilation, averaged across trials in a block, assessed in the lab
|
From enrollment to the end of participation at 6 weeks
|
|
QuickSIN SNR Loss
Time Frame: Days 1, 6, and 14 of the two-week auditory training
|
A speech-in-noise test assessed as part of the at-home auditory training program
|
Days 1, 6, and 14 of the two-week auditory training
|
|
Hearing Handicap Inventory
Time Frame: Days 1 and 14 of the two-week auditory training program
|
A listening effort questionnaire given as part of the at-home auditory training program
|
Days 1 and 14 of the two-week auditory training program
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elin Roverud, AuD, PhD, Boston University Charles River Campus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7799E
- R21DC021763 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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