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Behavioural Intervention

Brain Stimulation for Speech Improvement

N/A

Recruiting

Led By David Ostry

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal hearing

Be between 18 and 65 years old

Must not have

Psychoactive medications

Cochlear implant or tinnitus (ringing in ears)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours after learning (re-test lasts 30 minutes)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new way of learning how to speak better. The researchers believe that improving speech involves changes not only in the parts of the brain that control movement but also in the areas related

Who is the study for?

This trial is for right-handed individuals who speak fluent English, have normal hearing, and no speech or reading disabilities. It's not suitable for those with metal implants, neurostimulators, cochlear implants, a history of neurological disorders or concussion, on psychoactive medications, pregnant women, or anyone with certain heart devices.

What is being tested?

The study is examining how the brain learns and retains speech. Participants will undergo fMRI scans and different types of brain stimulation (single pulse TMS and cTBS) to see how these affect learning new speaking skills.

What are the potential side effects?

Brain stimulation may cause discomfort at the site of application, headache, lightheadedness or seizures in very rare cases. The fMRI is non-invasive but requires lying still in a loud machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have normal hearing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a cochlear implant or experience ringing in my ears.

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I or my family have a history of epilepsy, neurological disorders, or I've had a concussion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours after learning (re-test lasts 30 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours after learning (re-test lasts 30 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after learning (re-test lasts 30 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Retention of learning

Speech motor learning

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Speech Motor Learning and Retention Aim 3Experimental Treatment2 Interventions

Aim 3: Participants will have fMRI with behavioral measures of speech motor learning.

Group II: Speech Motor Learning and Retention Aim 2Experimental Treatment2 Interventions

Aim 2: Participants will perform learning tasks combined with shifted auditory feedback. Motor cortical excitability will be measured using single-pulse TMS to elicit motor evoked potentials.

Group III: Speech Motor Learning and Retention Aim 1Experimental Treatment2 Interventions

Aim 1: Participants will perform learning tasks while receiving altered/unaltered auditory feedback with cTBS applied to the appropriate area of the brain following learning. Retention of learning is assessed 24 hours later.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

continuous theta-burst stimulation (cTBS)

2022

N/A

~60

fMRI

2019

Completed Phase 3

~1730