StutteringNCT05306782
Shaping Motor Neural Functioning of Developmental Stuttering to Improve Fluency
A study testing transcranial Electrical Stimulation and Speech Therapy in people with Stuttering, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Stuttering
- What is being tested?
- transcranial Electrical Stimulation and Speech Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 2 Apr 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
(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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stuttering
- Being tested
- transcranial Electrical Stimulation, Speech Therapy
- Keywords
- Developmental Stuttering, Neuromodulation, transcranial Electrical Stimulation, Speech Fluency, Motor Networks
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Electrical StimulationDevice
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 TherapyBehavioural
Speech Therapy is associated to transcranial electrical stimulation or sham, during stimulation sessions. Total duration of the single session: 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Device: transcranial Electrical Stimulation; Behavioral: Speech Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])
Measured: 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
Measured: 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)
Measured: Evaluated immediately after the end of treatments
Secondary outcomes (7)
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])
Measured: 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])
Measured: 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])
Measured: 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
Measured: 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)
Measured: 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])
Measured: 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])
Measured: Evaluated about 6 weeks after the end of treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start2 Apr 2022
- Primary completion31 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StutteringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierpaolo Busan, IRCCS San Camillo, Venezia, Italy
- Investigators
- Pierpaolo Busan, Dr., Principal investigator, IRCCS Ospedale San Camillo s.r.l.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306782
- Sponsor's protocol ID
- GR-2018-12366027
- Status last verified
- Oct 2024
- First submitted
- 26 Feb 2022
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Persistent Developmental Stuttering: Shaping of Motor Neural Functioning to Improve Fluency
- ClinicalTrials.gov ID
- NCT05306782
- Acronym / sponsor ID
- GR-2018-12366027
- Conditions
- Stuttering
- Keywords
- Developmental Stuttering, Neuromodulation, transcranial Electrical Stimulation, Speech Fluency, Motor Networks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcranial Random Noise Stimulation | Experimental | Device: transcranial Electrical Stimulation, Behavioral: Speech TherapyTranscranial 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 | Experimental | Device: transcranial Electrical Stimulation, Behavioral: Speech TherapyTranscranial 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 Direct Current/Random Noise Stimulation | Sham comparator | Device: transcranial Electrical Stimulation, Behavioral: Speech TherapySham 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). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial Electrical Stimulationtranscranial 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). | Device | Sham Direct Current/Random Noise Stimulation, Transcranial Direct Current Stimulation, Transcranial Random Noise Stimulation |
| Speech TherapySpeech Therapy is associated to transcranial electrical stimulation or sham, during stimulation sessions. Total duration of the single session: 45 minutes | Behavioural | Sham Direct Current/Random Noise Stimulation, Transcranial Direct Current Stimulation, Transcranial Random Noise Stimulation |
Primary outcome
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])
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
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)
7 secondary outcomes
Stuttering Severity (subjective perception) (change from baseline)
Time frame: Evaluated immediately after the end of treatments
Stuttering Severity (subjective perception) (change from baseline)
Time frame: Evaluated about 6 weeks after the end of treatments
Speech Fluency and Stuttering Severity (change from baseline)
Time frame: Evaluated about 6 weeks after the end of treatments
TMS-induced (Motor) Evoked Potentials (change from baseline)
Time frame: Evaluated about 6 weeks after the end of treatments
EEG (change from baseline)
Time frame: Evaluated about 6 weeks after the end of treatments
Cognitive/behavioral indexes (associated with stuttering) (change from baseline)
Time frame: Evaluated immediately after the end of treatments
Cognitive/behavioral indexes (associated with stuttering) (change from baseline)
Time frame: Evaluated about 6 weeks after the end of treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Stuttering
Recruiting
Using Non-invasive Brain Stimulation to Explore Potential Treatments to Reduce Speech Errors in Adults Who Stutter
Stuttering, Fluency Disorder
Recruiting
Network Connectivity and Temporal Processing in Adolescents Who Stutter
Stuttering, Childhood, Stuttering
Recruiting
Transcranial Alternating Current Stimulation (tACS) in Stuttering
Stuttering, Adult, Stuttering, Childhood
Not yet recruiting
Effectiveness of Virtually Simulated Intervention for Patients Having Stuttering
Stuttering
Not yet recruiting
Development and Pilot Testing of Virtually Simulated Intervention for Patients Having Stuttering
Stuttering
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierpaolo Busan, Dr. principal investigator
IRCCS Ospedale San Camillo s.r.l.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Electrical Stimulation and Speech Therapy in people with Stuttering, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Fluency and Stuttering Severity (change from baseline) (time frame: Evaluated immediately after the end of treatments). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.