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Speech Sequencing Therapies for Stuttering
N/A
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated at baseline and immediately following intervention
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My hearing is good at specific test frequencies.
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My child has passed a hearing test at the required levels.
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My child will undergo tests to check their speech, hearing, and thinking skills.
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I am healthy with no history of brain, speech, or hearing problems.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain activity measured with functional magnetic resonance imaging
Change from baseline in production error rate
Change from baseline in reaction time
+2 moreSecondary outcome measures
Cortical morphometry
Cortical white matter connectivity
Forward digit span
+2 moreTrial 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
~580
Find a Location
Who is running the clinical trial?
Boston University Charles River CampusLead Sponsor
113 Previous Clinical Trials
11,846 Total Patients Enrolled
University of MichiganOTHER
1,794 Previous Clinical Trials
6,373,601 Total Patients Enrolled
4 Trials studying Stuttering
1,269 Patients Enrolled for Stuttering
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,040 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hearing is good at specific test frequencies.I am healthy with no history of brain, speech, or hearing problems, except for stuttering.I am not on medications that could affect my speech or language.You cannot participate in MRI studies if you have had seizures, severe claustrophobia, metal implants in your body, or if you are pregnant.You cannot participate if you have metal implants in your head, certain medical devices in your body, a history of seizures, significant scalp injuries, or if you are pregnant.My child is between 6 and 8 years old and does not have a neurological disorder except for stuttering.My child has passed a hearing test at the required levels.My child will undergo tests to check their speech, hearing, and thinking skills.You need to have normal vision or wear glasses or contacts to correct your vision.I performed within the normal range for my age in a specific memory test.I am healthy with no history of brain, speech, or hearing problems.People with PPA must have mild cognitive impairment or mild dementia.I can safely undergo tDCS or MRI procedures.People who have trouble speaking fluently will be checked by a speech expert to see how severe their stuttering is and to make sure there are no other speech or language problems.
Research Study Groups:
This trial has the following groups:- Group 1: Sub-syllabic learning and sham tDCS
- Group 2: Sub-syllabic learning and anodal tDCS of inferior frontal sulcus
- Group 3: Multisyllabic learning in children
- Group 4: Multisyllabic learning and fMRI in adults
- Group 5: Sub-syllabic learning and fMRI
- Group 6: Sub-syllabic learning in PPA
- Group 7: Sub-syllabic learning and anodal tDCS of cerebellum
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goal is this clinical experiment attempting to achieve?
"This medical study will observe and measure changes in reaction time as the primary outcome. Subsidiary objectives include assessing cortical white matter connectivity, stuttering severity (using The Stuttering Severity Instrument), and forward digit span scores from a Uniform Data Set neuropsychological test battery for correlations between phonological working memory and task performance. Evaluations of these metrics shall occur both at baseline and immediately following intervention."
Answered by AI
Is this clinical investigation recruiting participants right now?
"Alas, according to the information on clinicaltrials.gov this investigation is not currently enrolling patients - it was initially listed on July 1st 2022 and has since been updated June 27th 2022. Though this trial has ceased its recruitment process, 128 other studies are actively searching for participants at present."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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