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Speech Sequencing Therapies for Stuttering

N/A

Recruiting

Led By Frank H Guenther, PhD

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

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

Must have

Adult participants must pass a standard pure-tone hearing screening at a 25dB hearing level threshold at 500, 1k, 2k, and 4kHz frequencies

Participating children must pass a hearing screening at a 20 dB threshold at 500, 1k, 2k, and 4k Hz

Must not have

Participants with PPA taking medications that would be expected to affect speech or language are excluded

Participating children with a history of neurological disorder other than stuttering, and children under the age of 6 and over the age of 8 are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated at baseline and immediately following intervention

Summary

This trial is testing hypotheses about the brain processes involved in speech production in order to improve understanding of stuttering and develop new therapies.

Who is the study for?

This trial is for native American English speakers with limited second language exposure. It includes children who pass a hearing test, adults without neurological issues (except stuttering), and those diagnosed with primary progressive aphasia by MGH-FTD. Excluded are individuals with contraindications to MRI or tDCS, certain medication use in PPA patients, severe cognitive impairment, and outside the age range for child participants.

What is being tested?

The study investigates brain mechanisms in speech motor planning through experiments involving speech production tasks, functional MRI scans, and non-invasive brain stimulation like sham and anodal tDCS. Participants will learn new phoneme combinations or multisyllabic nonwords across multiple sessions to help understand these processes in people with stuttering or neurodegenerative speech disorders.

What are the potential side effects?

There may be minimal side effects from participating in this study. The most common would be discomfort from wearing an MRI scanner head coil or mild skin irritation under the electrodes used during tDCS. There's also a small risk of seizures during tDCS for those predisposed.

Eligibility Criteria

Inclusion Criteria

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

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My hearing is good at specific test frequencies.

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My child has passed a hearing test at the required levels.

Exclusion Criteria

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

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I am not on medications that could affect my speech or language.

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My child is between 6 and 8 years old and does not have a neurological disorder except for stuttering.

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I performed within the normal range for my age in a specific memory test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated at baseline and immediately following intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated at baseline and immediately following intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated at baseline and immediately following intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Brain activity measured with functional magnetic resonance imaging

Change from baseline in production error rate

Change from baseline in reaction time

+2 more

Secondary study objectives

Cortical morphometry

Cortical white matter connectivity

Forward digit span

+2 more

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: Sub-syllabic learning in PPAExperimental Treatment1 Intervention

30 adults with primary progressive aphasia (PPA) will participate in this arm. Subjects will learn novel 1-syllable nonsense words formed by non-native phoneme combinations during 8 training sessions over 2 days. Following training, subjects will complete a behavioral test to compare their performance on the words learned during training with a set of unfamiliar words also formed by non-native phoneme combinations.

Group II: Sub-syllabic learning and fMRIExperimental Treatment1 Intervention

60 adults with neurotypical speech development will participate in this arm. Subjects will learn novel 1-syllable nonsense words formed by non-native phoneme combinations during 6 training sessions over 2 days. Following training, subjects will participate in a functional magnetic resonance imaging (fMRI) session on a third day to measure brain activity associated with producing the words learned during training and with a set of unfamiliar words also formed by non-native phoneme combinations.

Group III: Sub-syllabic learning and anodal tDCS of inferior frontal sulcusExperimental Treatment2 Interventions

35 adults with neurotypical speech development will participate in this arm. Subjects will learn novel 1-syllable nonsense words formed by non-native phoneme combinations. During the training, anodal transcranial direct current stimulation (tDCS) will be applied to the the subject's left inferior frontal sulcus.

Group IV: Sub-syllabic learning and anodal tDCS of cerebellumExperimental Treatment2 Interventions

35 adults with neurotypical speech development will participate in this arm. Subjects will learn novel 1-syllable words formed by non-native phoneme combinations. During the training, continuous anodal transcranial direct current stimulation (tDCS) will be applied to the the subject's right cerebellum.

Group V: Multisyllabic learning in childrenExperimental Treatment1 Intervention

45 children with persistent developmental stuttering (CWS) and 45 children with neurotypical speech development (CNS) will participate in this arm. Subjects will learn nonsense words formed by novel combinations of 2 syllables that are legal in American English during 6 training sessions over 2 days. Behavioral measures extracted from the data will be used to compare performance before and after training and across the CWS and CNS participants.

Group VI: Multisyllabic learning and fMRI in adultsExperimental Treatment1 Intervention

30 adults persistent developmental stuttering (AWS) and 30 adults with neurotypical speech development (ANS) will participate in this arm. Subjects will learn nonsense words formed by novel combinations of 3 syllables that are legal in American English during 6 training sessions over 2 days. Following training, subjects will participate in a functional magnetic resonance imaging (fMRI) session on a third day to measure brain activity associated with producing the words formed by pairing 2 learned 3-syllable strings learned during training and those formed by pairing 2 unfamiliar 3-syllable strings. Behavioral measures extracted from the data will be used to compare performance before and after training and across the AWS and ANS participants.

Group VII: Sub-syllabic learning and sham tDCSPlacebo Group2 Interventions

35 adults with neurotypical speech development will participate in this arm. Subjects will learn novel 1-syllable words formed by non-native phoneme combinations. During training, Sham transcranial direct current stimulation stimulation (tDCS) will be delivered to the subject's brain.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anodal tDCS

2010

Completed Phase 2

~700

0 / 5Eligibility criteria met