Transcranial Stimulation Combined With Auditory Training

NCT06738030 | Not Yet Recruiting

• 2 other identifiers: 7799ER21DC021763
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Difficulties Understanding Speech in Noise

Outcome Measures

Primary Outcomes (4)

• Speech-on-speech intelligibility percent correct

  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

  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

  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

  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

Study Arms (2)

Active transcranial stimulation

EXPERIMENTAL

This group will receive active transcranial alternating current stimulation that matches the envelope of the target speech.

Device: Transcranial current stimulation; Behavioral: Auditory training

Sham stimulation

SHAM COMPARATOR

This group will receive transcranial stimulation that ramps on and off before the speech is presented.

Behavioral: Auditory training

Interventions

Transcranial current stimulation DEVICE

The transcranial alternating current stimulation is delivered during the speech stimulus and the current matches the envelope of the target speech

Active transcranial stimulation

Auditory training BEHAVIORAL

An at-home auditory training program that adaptively and interactively trains the listener in degraded speech, cognitive skills, and communication strategies

Active transcranial stimulation; Sham stimulation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Communication Neuroscience Research Lab at Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Elin Roverud, AuD, PhD

CONTACT

617-358-7440; erover@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to active transcranial stimulation or sham stimulation groups.

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 17, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: This data will be available no later than the end of the grant performance period (9/2026) and will be available indefinitely.
• Access Criteria: This data will be accessible to anyone via the stable URL link managed by the BU library.

Locations

US (1)