Stuttering
Conditions
Keywords
Developmental Stuttering, Neuromodulation, transcranial Electrical Stimulation, Speech Fluency, Motor Networks
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.
Interventions
DEVICEtranscranial Electrical Stimulation
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).
BEHAVIORALSpeech Therapy
Speech Therapy is associated to transcranial electrical stimulation or sham, during stimulation sessions. Total duration of the single session: 45 minutes
Sponsors
IRCCS San Camillo, Venezia, Italy
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants will be randomly assigned to real neuromodulation or to sham modulation (in addition to speech therapy)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Fluency and Stuttering Severity (change from baseline) | 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) | Evaluated immediately after the end of treatments | Utilization of Transcranial Magnetic Stimulation to evaluate excitability (and reactivity) of motor cortex |
| EEG (change from baseline) | Evaluated immediately after the end of treatments | Utilization of EEG to evaluate brain functioning and brain connectivity (delta, theta, alpha, beta, and gamma activity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG (change from baseline) | Evaluated about 6 weeks after the end of treatments | Utilization of EEG to evaluate brain functioning and brain connectivity (delta, theta, alpha, beta, and gamma activity) |
| Stuttering Severity (subjective perception) (change from baseline) | Evaluated immediately after the end of treatments | Utilization of (subjective) scales to evaluate stuttering severity/speech fluency (e.g. Premonitory Awareness in Stuttering Scale \[range 0-42; higher values indicate higher invasiveness of stuttering with respect to quality of life\]) |
| Cognitive/behavioral indexes (associated with stuttering) (change from baseline) | Evaluated immediately after the end of treatments | Utilization of (subjective) scales to evaluate cognitive/behavioral reactions (e.g. Beck Depression Inventory \[range 0-63; higher values indicate higher presence of depressive symptoms\]) |
| Speech Fluency and Stuttering Severity (change from baseline) | Evaluated about 6 weeks 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) | Evaluated about 6 weeks after the end of treatments | Utilization of Transcranial Magnetic Stimulation to evaluate excitability (and reactivity) of motor cortex |
Countries
Italy
Outcome results
None listed