Shaping Motor Neural Functioning of Developmental Stuttering to Improve

Status Recruiting

Clinical Trial Summary

Developmental stuttering (DS) is a motor/speech disorder, characterized by specific alterations in the functioning of brain circuits. Non-invasive brain stimulation may be useful to shape the altered functioning and connectivity of these systems. As a consequence, this project aims to expand the neurophysiological understanding of DS, evaluating effects of transcranial electrical stimulation (tES) on speech fluency and brain functioning of adults with persistent DS. This project will provide high-impact insights into the functioning of DS neural system, also proposing innovative and/or personalized rehabilitation.

Clinical Trial Description

Investigators will evaluate the effect of different tES protocols targeting motor associative regions (about 10 "consecutive" stimulation sessions, in different days; tES will be compared to sham stimulation), in association with "canonical" speech therapy. About 30 right-handed adults with idiopathic and persistent DS since childhood will be recruited (age 18-59 years; please see below for inlusion/exclusion criteria). Participants will be subdivided in three groups (in association to speech therapy): two groups will undergo transcranial random noise stimulation or transcranial direct current stimulation, while the third group will undergo sham (placebo) stimulation . Effects will be assessed by measuring stuttering severity (i.e. objective evaluation of stuttering), behavioral/cognitive scales (i.e. subjective evaluation of stuttering), as well as a series of neurophysiological indexes useful to evaluate brain functioning and connectivity (e.g. TMS[transcranial magnetic stimulation]-induced motor/evoked potentials and EEG brain activity). Evaluations will be realized before the start of the tES protocols, as well as at the end of the cycles. Follow-up evaluations (starting from about 6 weeks after completion of stimulation sessions) are also foreseen after the end of the treatments. ;

Study Design

Related Conditions & MeSH terms

Stuttering

Clinical Trial Details

NCT number	NCT05306782
Study type	Interventional
Source	IRCCS San Camillo, Venezia, Italy
Contact	Pierpaolo Busan, Dr.
Phone	+39 041 2207 501
Email	pierpaolo.busan@hsancamillo.it
Status	Recruiting
Phase	N/A
Start date	April 2, 2022
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
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Not yet recruiting	`NCT05437627` - Computerized Based Analysis for Detection and Severity Assessment of Stuttering
Completed	`NCT02288598` - Enhancing Speech Fluency With Non-invasive Brain Stimulation in Developmental Stuttering	N/A
Completed	`NCT00001602` - Genetic Factors Related to Stuttering	N/A
Active, not recruiting	`NCT04082104` - Assessment of Stuttering Severity in Adults and Adolescences in Conversational and Narrative Contexts
Completed	`NCT04580966` - IBSR Intervention for Adults Who Stutter	N/A
Recruiting	`NCT00148161` - Activity of the Auditory Cortex During Speech Perception and Speech Production in Stuttering	N/A
Recruiting	`NCT05908123` - Exploring the Nature, Assessment and Treatment of Stuttering	N/A
Completed	`NCT00001551` - Characteristics of Idiopathic Familial Speech Disorders	N/A
Withdrawn	`NCT01315730` - The Effects of Tactile Speech Feedback on Stuttering Frequency	Phase 1
Completed	`NCT00004991` - Study of Brain Activity During Speech Production and Speech Perception	N/A
Recruiting	`NCT05286151` - Network Connectivity and Temporal Processing in Adolescents Who Stutter	N/A
Completed	`NCT00001604` - Genetic Linkage Studies of Stuttering
Recruiting	`NCT00680303` - Spacing Lidcombe Program Clinic Visits	Phase 2
Recruiting	`NCT00709072` - Follow-up of Children After Stuttering Treatment	Phase 2
Completed	`NCT00830154` - A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering	Phase 2/Phase 3
Completed	`NCT03698539` - How Stuttering and Gestures Influence the Intelligibility of Individuals With Down Syndrome
Completed	`NCT04505696` - Providing Speech Therapy Awareness in Private Schools	N/A
Recruiting	`NCT04929184` - Speech Processing in Stuttering	N/A
Terminated	`NCT00001308` - Central Mechanisms in Speech Motor Control Studied With H215O PET

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Shaping Motor Neural Functioning of Developmental Stuttering to Improve Fluency

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms