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Shaping Motor Neural Functioning of Developmental Stuttering to Improve Fluency

Primary Purpose

Stuttering

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
transcranial Electrical Stimulation
Speech Therapy
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stuttering focused on measuring Developmental Stuttering, Neuromodulation, transcranial Electrical Stimulation, Speech Fluency, Motor Networks

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

(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).

Sites / Locations

  • IRCCS Ospedale San CamilloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Transcranial Random Noise Stimulation

Transcranial Direct Current Stimulation

Sham Direct Current/Random Noise Stimulation

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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])
TMS-induced (Motor) Evoked Potentials (change from baseline)
Utilization of Transcranial Magnetic Stimulation to evaluate excitability (and reactivity) of motor cortex
EEG (change from baseline)
Utilization of EEG to evaluate brain functioning and brain connectivity (delta, theta, alpha, beta, and gamma activity)

Secondary Outcome Measures

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])
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])
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])
TMS-induced (Motor) Evoked Potentials (change from baseline)
Utilization of Transcranial Magnetic Stimulation to evaluate excitability (and reactivity) of motor cortex
EEG (change from baseline)
Utilization of EEG to evaluate brain functioning and brain connectivity (delta, theta, alpha, beta, and gamma activity)
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])
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])

Full Information

First Posted
February 26, 2022
Last Updated
July 10, 2023
Sponsor
IRCCS San Camillo, Venezia, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT05306782
Brief Title
Shaping Motor Neural Functioning of Developmental Stuttering to Improve Fluency
Official Title
The Treatment of Persistent Developmental Stuttering: Shaping of Motor Neural Functioning to Improve Fluency
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering
Keywords
Developmental Stuttering, Neuromodulation, transcranial Electrical Stimulation, Speech Fluency, Motor Networks

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants will be randomly assigned to "real" neuromodulation or to "sham" modulation (in addition to speech therapy)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Random Noise Stimulation
Arm Type
Experimental
Arm Description
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).
Arm Title
Transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham Direct Current/Random Noise Stimulation
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
transcranial Electrical Stimulation
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Speech Therapy
Intervention Description
Speech Therapy is associated to transcranial electrical stimulation or sham, during stimulation sessions. Total duration of the single session: 45 minutes
Primary Outcome Measure Information:
Title
Speech Fluency and Stuttering Severity (change from baseline)
Description
Utilization of (objective) scales to evaluate stuttering severity and speech fluency (Stuttering Severity Instrument [range 0-56; higher values indicate higher numbers of dysfluencies])
Time Frame
Evaluated immediately after the end of treatments
Title
TMS-induced (Motor) Evoked Potentials (change from baseline)
Description
Utilization of Transcranial Magnetic Stimulation to evaluate excitability (and reactivity) of motor cortex
Time Frame
Evaluated immediately after the end of treatments
Title
EEG (change from baseline)
Description
Utilization of EEG to evaluate brain functioning and brain connectivity (delta, theta, alpha, beta, and gamma activity)
Time Frame
Evaluated immediately after the end of treatments
Secondary Outcome Measure Information:
Title
Stuttering Severity (subjective perception) (change from baseline)
Description
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])
Time Frame
Evaluated immediately after the end of treatments
Title
Stuttering Severity (subjective perception) (change from baseline)
Description
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])
Time Frame
Evaluated about 6 weeks after the end of treatments
Title
Speech Fluency and Stuttering Severity (change from baseline)
Description
Utilization of (objective) scales to evaluate stuttering severity and speech fluency (Stuttering Severity Instrument [range 0-56; higher values indicate higher numbers of dysfluencies])
Time Frame
Evaluated about 6 weeks after the end of treatments
Title
TMS-induced (Motor) Evoked Potentials (change from baseline)
Description
Utilization of Transcranial Magnetic Stimulation to evaluate excitability (and reactivity) of motor cortex
Time Frame
Evaluated about 6 weeks after the end of treatments
Title
EEG (change from baseline)
Description
Utilization of EEG to evaluate brain functioning and brain connectivity (delta, theta, alpha, beta, and gamma activity)
Time Frame
Evaluated about 6 weeks after the end of treatments
Title
Cognitive/behavioral indexes (associated with stuttering) (change from baseline)
Description
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])
Time Frame
Evaluated immediately after the end of treatments
Title
Cognitive/behavioral indexes (associated with stuttering) (change from baseline)
Description
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])
Time Frame
Evaluated about 6 weeks after the end of treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
(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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierpaolo Busan, Dr.
Phone
+39 041 2207 501
Email
pierpaolo.busan@hsancamillo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierpaolo Busan, Dr.
Organizational Affiliation
IRCCS Ospedale San Camillo s.r.l.
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Ospedale San Camillo
City
Venice
ZIP/Postal Code
30126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierpaolo Busan, Dr.
Phone
+39 041 2207 501
Email
pierpaolo.busan@hsancamillo.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Shaping Motor Neural Functioning of Developmental Stuttering to Improve Fluency

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