An interventional study of transcranial Electrical Stimulation and Speech Therapy in Stuttering, sponsored by IRCCS San Camillo, Venezia, Italy. Completed at 1 site in Italy. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by IRCCS San Camillo, Venezia, Italy · Not applicable, Interventional, and Basic science
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.
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.
74 studies on the registry are indexed under Stuttering; 23 are open to participants now.
This study's enrollment of 24 is below the median of 44 across 57 interventional studies indexed under Stuttering.
Browse Stuttering studies →IRCCS San Camillo, Venezia, Italy is the lead sponsor of 48 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(main) Inclusion Criteria:
-Right-handed adults with idiopathic, persistent DS since childhood
(main) Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 (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 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
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 is associated to transcranial electrical stimulation or sham, during stimulation sessions. Total duration of the single session: 45 minutes
Speech Fluency and Stuttering Severity (change from baseline)
Utilization of (objective) scales to evaluate stuttering severity and speech fluency (Stuttering Severity Instrument \[range 0-56; higher values indicate higher numbers of dysfluencies\])
Time frame: 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
Time frame: 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)
Time frame: 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 \[range 0-42; higher values indicate higher "invasiveness" of stuttering with respect to quality of life\])
Time frame: 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 \[range 0-42; higher values indicate higher "invasiveness" of stuttering with respect to quality of life\])
Time frame: 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 \[range 0-56; higher values indicate higher numbers of dysfluencies\])
Time frame: 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
Time frame: 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)
Time frame: 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 \[range 0-63; higher values indicate higher presence of depressive symptoms\])
Time frame: 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 \[range 0-63; higher values indicate higher presence of depressive symptoms\])
Time frame: Evaluated about 6 weeks after the end of treatments
Plan to share: No
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IRCCS San Camillo, Venezia, Italy