Transcranial Stimulation Combined With Auditory Training

NCT ID: NCT06738030

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-20

Study Completion Date

2026-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Difficulties Understanding Speech in Noise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to active transcranial stimulation or sham stimulation groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active transcranial stimulation

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

Group Type EXPERIMENTAL

Transcranial current stimulation

Intervention Type DEVICE

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

Auditory training

Intervention Type BEHAVIORAL

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

Sham stimulation

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

Group Type SHAM_COMPARATOR

Auditory training

Intervention Type BEHAVIORAL

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

Interventions

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Transcranial current stimulation

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

Intervention Type DEVICE

Auditory training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Communication Neuroscience Research Lab at Boston University

Boston, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Elin Roverud, AuD, PhD

Role: CONTACT

Phone: 617-358-7440

Email: [email protected]

Facility Contacts

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Tyler Perrachione, PhD

Role: primary

Monique Montoute

Role: backup

Other Identifiers

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R21DC021763

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7799E

Identifier Type: -

Identifier Source: org_study_id