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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
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(main) Inclusion Criteria:
-Right-handed adults with idiopathic, persistent DS since childhood
(main) Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierpaolo Busan, Dr. | IRCCS Ospedale San Camillo s.r.l. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Camillo | Venice | 30126 | Italy |
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| ID | Term |
|---|---|
| D013342 | Stuttering |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D013070 | Speech Therapy |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Participants will be randomly assigned to "real" neuromodulation or to "sham" modulation (in addition to speech therapy)
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| Speech Therapy | Behavioral | Speech Therapy is associated to transcranial electrical stimulation or sham, during stimulation sessions. Total duration of the single session: 45 minutes |
|
| 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 |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |