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Completed

NCT Number: NCT05306782

Shaping Motor Neural Functioning of Developmental Stuttering to Improve Fluency

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.

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Key information

Conditions

Stuttering Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Ospedale San Camillo

Venice, 30126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

(main) Inclusion Criteria:

-Right-handed adults with idiopathic, persistent DS since childhood

(main) Exclusion Criteria:

  • Contraindications to non-invasive brain stimulation;
  • Currently assumption of drugs acting on the Central Nervous System;
  • Presence of overt neurological/psychiatric/medical conditions or overt comorbidities (e.g. obsessive-compulsive disorder).

Treatment and study plan

Transcranial Electrical Stimulation

Device

transcranial Random Noise Stimulation, transcranial Direct Current Stimulation, or Sham are administered (by means of surface electrodes) on associative motor regions during speech therapy sessions (20 minutes, in the initial part of the sessions; 1.5 mA).

Speech Therapy

Behavioral

Speech Therapy is associated to transcranial electrical stimulation or sham, during stimulation sessions. Total duration of the single session: 45 minutes

Primary outcomes

  1. Speech Fluency and Stuttering Severity (change from baseline)

    Time frame: Evaluated immediately after the end of treatments

    Utilization of (objective) scales to evaluate stuttering severity and speech fluency (Stuttering Severity Instrument [range 0-56; higher values indicate higher numbers of dysfluencies])

  2. TMS-induced (Motor) Evoked Potentials (change from baseline)

    Time frame: Evaluated immediately after the end of treatments

    Utilization of Transcranial Magnetic Stimulation to evaluate excitability (and reactivity) of motor cortex

  3. EEG (change from baseline)

    Time frame: Evaluated immediately after the end of treatments

    Utilization of EEG to evaluate brain functioning and brain connectivity (delta, theta, alpha, beta, and gamma activity)

Secondary outcomes

  1. Stuttering Severity (subjective perception) (change from baseline)

    Time frame: Evaluated immediately after the end of treatments

    Utilization of (subjective) scales to evaluate stuttering severity/speech fluency (e.g. Premonitory Awareness in Stuttering Scale [range 0-42; higher values indicate higher "invasiveness" of stuttering with respect to quality of life])

  2. Stuttering Severity (subjective perception) (change from baseline)

    Time frame: Evaluated about 6 weeks after the end of treatments

    Utilization of (subjective) scales to evaluate stuttering severity/speech fluency (e.g. Premonitory Awareness in Stuttering Scale [range 0-42; higher values indicate higher "invasiveness" of stuttering with respect to quality of life])

  3. Speech Fluency and Stuttering Severity (change from baseline)

    Time frame: Evaluated about 6 weeks after the end of treatments

    Utilization of (objective) scales to evaluate stuttering severity and speech fluency (Stuttering Severity Instrument [range 0-56; higher values indicate higher numbers of dysfluencies])

  4. TMS-induced (Motor) Evoked Potentials (change from baseline)

    Time frame: Evaluated about 6 weeks after the end of treatments

    Utilization of Transcranial Magnetic Stimulation to evaluate excitability (and reactivity) of motor cortex

  5. EEG (change from baseline)

    Time frame: Evaluated about 6 weeks after the end of treatments

    Utilization of EEG to evaluate brain functioning and brain connectivity (delta, theta, alpha, beta, and gamma activity)

  6. Cognitive/behavioral indexes (associated with stuttering) (change from baseline)

    Time frame: Evaluated immediately after the end of treatments

    Utilization of (subjective) scales to evaluate cognitive/behavioral reactions (e.g. Beck Depression Inventory [range 0-63; higher values indicate higher presence of depressive symptoms])

  7. Cognitive/behavioral indexes (associated with stuttering) (change from baseline)

    Time frame: Evaluated about 6 weeks after the end of treatments

    Utilization of (subjective) scales to evaluate cognitive/behavioral reactions (e.g. Beck Depression Inventory [range 0-63; higher values indicate higher presence of depressive symptoms])

Sponsors and collaborators

Lead sponsor

IRCCS San Camillo, Venezia, Italy

Other

Registry information

Official study title

The Treatment of Persistent Developmental Stuttering: Shaping of Motor Neural Functioning to Improve Fluency

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2022
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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