Clinical trial NCT05306782: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stuttering
Keywords: Developmental Stuttering
Neuromodulation
transcranial Electrical Stimulation
Speech Fluency
Motor Networks
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

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).

Primary outcomes:
measure: Speech Fluency and Stuttering Severity (change from baseline)
timeFrame: Evaluated immediately after the end of treatments
measure: TMS-induced (Motor) Evoked Potentials (change from baseline)
timeFrame: Evaluated immediately after the end of treatments
measure: EEG (change from baseline)
timeFrame: Evaluated immediately after the end of treatments
Secondary outcomes:
measure: Stuttering Severity (subjective perception) (change from baseline)
timeFrame: Evaluated immediately after the end of treatments
measure: Stuttering Severity (subjective perception) (change from baseline)
timeFrame: Evaluated about 6 weeks after the end of treatments
measure: Speech Fluency and Stuttering Severity (change from baseline)
timeFrame: Evaluated about 6 weeks after the end of treatments
measure: TMS-induced (Motor) Evoked Potentials (change from baseline)
timeFrame: Evaluated about 6 weeks after the end of treatments
measure: EEG (change from baseline)
timeFrame: Evaluated about 6 weeks after the end of treatments
measure: Cognitive/behavioral indexes (associated with stuttering) (change from baseline)
timeFrame: Evaluated immediately after the end of treatments
measure: Cognitive/behavioral indexes (associated with stuttering) (change from baseline)
timeFrame: Evaluated about 6 weeks after the end of treatments
Other outcomes:
Locations:
city: Venice
country: Italy
facility: IRCCS Ospedale San Camillo
Study officials:
affiliation: IRCCS Ospedale San Camillo s.r.l.
name: Pierpaolo Busan, Dr.
role: PRINCIPAL_INVESTIGATOR
References: