Shaping Motor Neural Functioning of Developmental Stuttering to Improve Fluency

NCT05306782 | Completed DMC

• 1 other identifier: GR-2018-12366027
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stuttering

Keywords

Developmental Stuttering; Neuromodulation; transcranial Electrical Stimulation; Speech Fluency; Motor Networks

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Stuttering Severity (subjective perception) (change from baseline)

  Evaluated immediately after the end of treatments

• Stuttering Severity (subjective perception) (change from baseline)

  Evaluated about 6 weeks after the end of treatments

• Speech Fluency and Stuttering Severity (change from baseline)

  Evaluated about 6 weeks after the end of treatments

• TMS-induced (Motor) Evoked Potentials (change from baseline)

  Evaluated about 6 weeks after the end of treatments

• EEG (change from baseline)

  Evaluated about 6 weeks after the end of treatments

Study Arms (3)

Transcranial Random Noise Stimulation

EXPERIMENTAL

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; Behavioral: Speech Therapy

Transcranial Direct Current Stimulation

EXPERIMENTAL

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; Behavioral: Speech Therapy

Sham Direct Current/Random Noise Stimulation

SHAM COMPARATOR

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; Behavioral: Speech Therapy

Interventions

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).

Sham Direct Current/Random Noise Stimulation; Transcranial Direct Current Stimulation; Transcranial Random Noise Stimulation

Speech Therapy BEHAVIORAL

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

Sham Direct Current/Random Noise Stimulation; Transcranial Direct Current Stimulation; Transcranial Random Noise Stimulation

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

IRCCS Ospedale San Camillo

Venice, 30126, Italy

Location

MeSH Terms

Conditions

Stuttering

Interventions

Transcranial Direct Current Stimulation; Speech Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Pierpaolo Busan, Dr.

  IRCCS Ospedale San Camillo s.r.l.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to "real" neuromodulation or to "sham" modulation (in addition to speech therapy)
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: April 1, 2022
• Study Start: April 2, 2022
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)