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IRCT20181215041975N1 IRCT 2019-01-02 Shiraz University of Medical Sciences Investigation of the effect of electrical stimulation of the brain on the basis of EEG in stuttering Electroencephalogram-Informed transcranial electrical stimulation together with speech therapy to remediate stuttering 2019-01-21 anticipated 30 Complete https://irct.ir/trial/36067 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, the use of stimulation based on electrophysiologic data analysis of individuals (personalized treatment) is going to compare to a common predetermined protocol in previous studies, Randomization description: Subjects were selected by random sampling from the community of stuttering adults. After meeting the inclusion and exclusion criteria of the study, they were assigned ,with a random number table, in one of two groups of study and control by simple random allocation method, Blinding description: The assessment of stuttering in the preceding, subsequent and follow-up intervention stages will be carried out by speech therapists who are blind to the assignment Participants will be blinded to the assignment Speech therapist is blind to the allocation so that after the assembly of the device and the installation of a non-transparent special hat by the operator, she enters the treatment room The brain signal recorders are blind to the allocation The brain signal analyzers are blind to the allocation The main researcher will be stayed blind up yo the end of the follow-up phase to the allocation. When the results of the stuttering assessment and brain signal analysis by the relevant agents at the end of the implementation of the plan were provided, the allocation information from the operator of the device, which is independent of the plan for analysis, will be received for statistical analyses. N/A STUTTERING. Intervention 1: Intervention group: Features in the electroencephalogram(EEG) signals related to fluent and non-fluent statements that determine the frequency and areas of electric stimulation will be determined in each subject. َThe montage and type of electrical stimulation will be selected based on the significant differences between the two modes of fluent and non-fluent statements in terms of power or phase coherence. Frequency bands and phase coherence affecting the speech fluency will be administered on areas marked with the 10 -20 system by direct (tDCS) or alternative (tACS) electrical stimulation. This stimulation together with speech therapy will be provided in two weeks, 5 days a week and 30 minutes a day. Intervention 2: Control group: Features in the EEG signals related to fluent and non-fluent statements that determine the frequency and areas of electric stimulation will be determined in each subject.The montage and type of electrical stimulation, based on the common protocol in stuttering, will be anodal tDCS stimulation over FC5(10-20 system) and reference electrode on supra orbital ridge. This stimulation together with speech therapy will be provided in two weeks, 5 days a week and 30 minutes a day. Yes - There is a plan to make this available What will be shared: The total individual participants' data is unobtrusive after being unidentified The report is a collaborative clinical study When: Access to individual data 6 months after publishing the results for one year Access to the clinical report after publishing the results for one year To whom: Researchers at universities Conditions: Commitment to mention the source name and principal researcher for any use Commitment to non-application for clinical purposes Where to obtain: Corresponding with the agent of project executor, Masoumeh Bayat, with the postal address: masumeh_bayat@yahoo.com How to obtain: Investigate the application by the agent of project executor (1 month), and sharing the application with the project executor (1 month), and final statement by the agent of project executor Comments:
public Masoumeh Batat
Unit 8, Number 22, Seifoori Alley, Mojahedin-e Eslam Ave, Shohada Sq
Tehran Iran (Islamic Republic of) 1156836449 +98 21 3350 2375 masumeh_bayat@yahoo.com Shiraz University of Medical Sciences scientific Mohammad Nami
The School of Advanced Medical Sciences and Technologies, Almas Building, Alley 29, Qasrodasht Ave
Shiraz Iran (Islamic Republic of) 7133654361 +98 71 3230 5471 torabinami@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Affected by developmental stuttering with moderate to very severe Persian speaking Right-handed Without sensory, linguistic, and cognitive problems Holding a diploma, at least male 18 years 54 years Male History of speech, language, cognitive, or hearing disorder( except for stuttering) according to self report Acquired and developmental neurological disorders Having a history of speech therapy from 3 months ago F98.5 Speech that is characterized by frequent repetition or prolongation of sounds or syllables or words, or by frequent hesitations or pauses that disrupt the rhythmic flow of speech. It should be classified as a disorder only if its severity is such as to ma Treatment - Devices Treatment - Devices Intervention group: Features in the electroencephalogram(EEG) signals related to fluent and non-fluent statements that determine the frequency and areas of electric stimulation will be determined in each subject. َThe montage and type of electrical stimulation will be selected based on the significant differences between the two modes of fluent and non-fluent statements in terms of power or phase coherence. Frequency bands and phase coherence affecting the speech fluency will be administered on areas marked with the 10 -20 system by direct (tDCS) or alternative (tACS) electrical stimulation. This stimulation together with speech therapy will be provided in two weeks, 5 days a week and 30 minutes a day. Control group: Features in the EEG signals related to fluent and non-fluent statements that determine the frequency and areas of electric stimulation will be determined in each subject.The montage and type of electrical stimulation, based on the common protocol in stuttering, will be anodal tDCS stimulation over FC5(10-20 system) and reference electrode on supra orbital ridge. This stimulation together with speech therapy will be provided in two weeks, 5 days a week and 30 minutes a day. Stuttering severity based on ssi-4 and oases. Timepoint: Measuring the stuttering severity at the beginning of the study, immediately after the intervention and three months after the intervention. Method of measurement: Stuttering severity instrument-4 edition and Overall assessment the speaker`s experience of stuttering--adults. Shiraz University of Medical Sciences Approved 2018-10-27 Ethics committee of Shiraz University of Medical Sciences Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran shiraz Fars Iran (Islamic Republic of)