Shaping Motor Neural Functioning of Developmental Stuttering to Improve Fluency

The Treatment of Persistent Developmental Stuttering: Shaping of Motor Neural Functioning 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.

Study Overview

• Status: Completed
• Conditions: Stuttering
• Intervention / Treatment: Device: transcranial Electrical Stimulation; Behavioral: Speech Therapy

Detailed 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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Venice, Italy, 30126
    • IRCCS Ospedale San Camillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

(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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial Random Noise Stimulation; Transcranial Random Noise Stimulation (1.5 mA, High Frequency) administered by using surface scalp electrodes (20 minutes, initial part of the session) in correspondence of associative motor regions, during speech therapy sessions (45 minutes).	Device: transcranial Electrical Stimulation; 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).; Behavioral: Speech Therapy; Speech Therapy is associated to transcranial electrical stimulation or sham, during stimulation sessions. Total duration of the single session: 45 minutes
Experimental: Transcranial Direct Current Stimulation; Transcranial Direct Current Stimulation (1.5 mA, anodal) administered by using surface scalp electrodes (20 minutes, initial part of the session) in correspondence of associative motor regions, during speech therapy sessions (45 minutes).	Device: transcranial Electrical Stimulation; 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).; Behavioral: Speech Therapy; Speech Therapy is associated to transcranial electrical stimulation or sham, during stimulation sessions. Total duration of the single session: 45 minutes
Sham Comparator: Sham Direct Current/Random Noise Stimulation; Sham stimulation administered by using surface scalp electrodes (20 minutes, initial part of the session) in correspondence of associative motor regions, during speech therapy sessions (45 minutes).	Device: transcranial Electrical Stimulation; 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).; Behavioral: Speech Therapy; Speech Therapy is associated to transcranial electrical stimulation or sham, during stimulation sessions. Total duration of the single session: 45 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Fluency and Stuttering Severity (change from baseline)	Utilization of (objective) scales to evaluate stuttering severity and speech fluency (Stuttering Severity Instrument [range 0-56; higher values indicate higher numbers of dysfluencies])	Evaluated immediately after the end of treatments
TMS-induced (Motor) Evoked Potentials (change from baseline)	Utilization of Transcranial Magnetic Stimulation to evaluate excitability (and reactivity) of motor cortex	Evaluated immediately after the end of treatments
EEG (change from baseline)	Utilization of EEG to evaluate brain functioning and brain connectivity (delta, theta, alpha, beta, and gamma activity)	Evaluated immediately after the end of treatments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stuttering Severity (subjective perception) (change from baseline)	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])	Evaluated immediately after the end of treatments
Stuttering Severity (subjective perception) (change from baseline)	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])	Evaluated about 6 weeks after the end of treatments
Speech Fluency and Stuttering Severity (change from baseline)	Utilization of (objective) scales to evaluate stuttering severity and speech fluency (Stuttering Severity Instrument [range 0-56; higher values indicate higher numbers of dysfluencies])	Evaluated about 6 weeks after the end of treatments
TMS-induced (Motor) Evoked Potentials (change from baseline)	Utilization of Transcranial Magnetic Stimulation to evaluate excitability (and reactivity) of motor cortex	Evaluated about 6 weeks after the end of treatments
EEG (change from baseline)	Utilization of EEG to evaluate brain functioning and brain connectivity (delta, theta, alpha, beta, and gamma activity)	Evaluated about 6 weeks after the end of treatments
Cognitive/behavioral indexes (associated with stuttering) (change from baseline)	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])	Evaluated immediately after the end of treatments
Cognitive/behavioral indexes (associated with stuttering) (change from baseline)	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])	Evaluated about 6 weeks after the end of treatments

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy
• Investigators: Principal Investigator: Pierpaolo Busan, Dr., IRCCS Ospedale San Camillo s.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2022
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: February 26, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Neuromodulation; Developmental Stuttering; transcranial Electrical Stimulation; Speech Fluency; Motor Networks
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stuttering
• Other Study ID Numbers: GR-2018-12366027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No