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IRCT20230907059369N1 IRCT 2023-12-05 Tehran University of Medical Sciences Investigation of the effect of the transcranial Direct Current Stimulation(tDCS) for improvement of speech fluency in adults who stutter Investigation of the effect of the combined treatment method of fluency shaping and transcranial Direct Current Stimulation(tDCS) for improvement of speech fluency in adults who stutter 2023-12-10 anticipated 62 Recruiting https://irct.ir/trial/72516 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation will take place on the website www.randomization.com. The randomization list will be created by a collaborator who is not involved in the study process. The following is the procedure: the number of groups and total sample size are entered into the appropriate section of the website. Each participant will be issued a unique code, which will be randomly assigned to either Group A or Group B. The control group is Group A, and the intervention group is Group B. In the following phase, we will use the sealed envelope method to conceal the website's constructed list. As a result, a sample size of sealed envelopes will be made, with the participant's code inscribed on each envelope. The letter A or B will be inserted inside each envelope based on the list. Thick envelopes will be used to ensure that the letter within the envelope is not visible. The list on the internet will then be deleted, Blinding description: One collaborator is in charge of regulating the stimulation delivery length of the tDCS device. When the participant turns over the sealed envelope to the collaborator, they decide how long the stimulation will last based on the letter inside. If the letter is A, the stimulation lasts 15 seconds, while the letter B lasts 20 minutes. Following that, the lead researcher continues on to the treatment's subsequent steps. As a result, the primary researcher, who leads the therapy sessions, is fully uninformed of the group designations. As can be seen, neither the participants nor the treatment provider know whether the individual is in the intervention or control group. Furthermore, the assessors who measure the primary and Secondary outcomes are not involved in any other aspect of the study.As a result, this study is a double-blind randomized controlled trial. 3 Developmental stuttering. Intervention 1: Intervention group:speech fluency shaping treatment and transcranial direct current stimulation treatment.The individual will undertake 6 rigorous sessions lasting 1 to 2 hours each for the therapy of speech fluency shaping. They will work with the therapist in the clinic to practice simple speech reconstruction procedures (phonemes, syllables, words, and small sentences or phrases). The purpose of this stage is for the participant to be able to use rudimentary speech reconstruction techniques (sentence level) during reading and monologue speech with the therapist before moving on to the combined intervention stage (speech therapy and brain stimulation). The researcher will give transcranial direct current stimulation (tDCS) to the left inferior frontal gyrus area (based on the worldwide 20-10 system) using the FC5 region during the transcranial direct current stimulation (tDCS) intervention using the Starstim model. Intervention 2: Control group:speech fluency shaping treatment.The individual will undertake 6 rigorous sessions lasting 1 to 2 hours each for the therapy of speech fluency shaping. They will work with the therapist in the clinic to practice simple speech reconstruction procedures (phonemes, syllables, words, and small sentences or phrases). The purpose of this stage is for the participant to be able to use rudimentary speech reconstruction techniques (sentence level) during reading and monologue speech with the therapist. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I understand that the participants in this research are adults with stuttering and may have a high sensitivity towards data publication. Therefore, I have not made a decision regarding the publication of data files at this time
public Kowsar Esfandeh
School of rehabilitation sciences, At the intersection of Safi Ali Shah Street, Shemiran Corner, Enghelab Street
Tehran Iran (Islamic Republic of) 65111-11489 +98 21 7753 3939 ksfande@gmail.com Tehran University of Medical Sciences scientific Kowsar Esfandeh
School of rehabilitation sciences, At the intersection of Safi Ali Shah Street, Shemiran Corner, Street, Enghelab street
Tehran Iran (Islamic Republic of) 65111-11489 +98 21 7753 3939 ksfande@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Range of ages between 18 and 50 Right-handedness History of developmental stuttering, with mild to very severe stuttering Not having stuttering treatment speech therapy within the month before the intervention Monolingual and Persian-speaker Normal visual and auditory abilities 18 years 50 years Both Other speech and language impairments, cognitive or psychological diseases, attention deficit hyperactivity disorder (ADHD), brain surgery, or tumors may coexist with stuttering History of seizures Intake of any medication that affects central nervous system functions, such as antiseizures and antidepression Cranial/brain metal implants Skin lesions and sensitivity of the scalp skin to stimulation F80 Specific developmental disorders of speech and language Rehabilitation Rehabilitation Intervention group:speech fluency shaping treatment and transcranial direct current stimulation treatment.The individual will undertake 6 rigorous sessions lasting 1 to 2 hours each for the therapy of speech fluency shaping. They will work with the therapist in the clinic to practice simple speech reconstruction procedures (phonemes, syllables, words, and small sentences or phrases). The purpose of this stage is for the participant to be able to use rudimentary speech reconstruction techniques (sentence level) during reading and monologue speech with the therapist before moving on to the combined intervention stage (speech therapy and brain stimulation). The researcher will give transcranial direct current stimulation (tDCS) to the left inferior frontal gyrus area (based on the worldwide 20-10 system) using the FC5 region during the transcranial direct current stimulation (tDCS) intervention using the Starstim model. Control group:speech fluency shaping treatment.The individual will undertake 6 rigorous sessions lasting 1 to 2 hours each for the therapy of speech fluency shaping. They will work with the therapist in the clinic to practice simple speech reconstruction procedures (phonemes, syllables, words, and small sentences or phrases). The purpose of this stage is for the participant to be able to use rudimentary speech reconstruction techniques (sentence level) during reading and monologue speech with the therapist Percentage of stuttered syllables. Timepoint: One week prior to the intervention, Immediately after the intervention, 6 weeks after the intervention, and 12 weeks after the intervention. Method of measurement: The percentage of stuttered syllables in unplanned telephone call is calculated in this study. The percentage is calculated as follows: The number of stuttered syllables in the speech sample is divided by the total number of syllables spoken in that speech sample, and then multiplied by 100. Each evaluation session consists of a 10-minute telephone call with an evaluator. Speech Naturalness. Timepoint: One week prior to the intervention, immediately after the intervention, 6 weeks after the intervention, and 12 weeks after the intervention. Method of measurement: The assessment of speech naturalness in this study will be done on a 9-point scale. A score of zero indicates that no speech treatment techniques were utilized, while a score of eight suggests that speech therapy techniques were used excessively. Severity rating. Timepoint: One week prior to the intervention, immediately after the intervention, 6 weeks after the intervention, and 12 weeks after the intervention. Method of measurement: The severity of stuttering will be graded on a 9-point scale in this study. A score of zero indicates no stuttering, a score of 1 and 2 indicates very very mild stuttering, a score of 3 indicates mild stuttering, a score of 4 and 5 indicates moderate stuttering, a score of 6 and 7 suggests severe stuttering, and a score of 8 indicates very severe stuttering. The severity of stuttering based on Severity Stuttering Instrument version-4. Timepoint: One week prior to the intervention and 12 weeks after the intervention. Method of measurement: This questionnaire assesses observable stuttering characteristics like frequency, duration, and associated bodily activities. In the current study, the Stuttering Severity Instrument-4 (SSI-4) is used to quantify the severity of stuttering in evaluations done one week before and 12 weeks after the intervention. Subtest scores and overall test scores will be recorded as dependent variables. The final score for this exam is calculated by adding the results of three subtests, including frequency, duration, and associated physical actions, and runs from 8 to 56.The duration subtest is based on the average of the three longest stuttering events, whereas the frequency subtest is based on the percentage of stuttering syllables in the speech sample and reading aloud (in literate people). In the associated physical behaviors subtest, a 6-point Likert scale (range from 0 to 5, indicating no associated physical behaviors) is used to assess the existence of physical behaviors accompanying stuttering in articulatory and body gestures. The severity of stuttering based on Overall Assessment of the Speaker's Experience of Stuttering. Timepoint: One week prior to the intervention and 12 weeks after the intervention. Method of measurement: A thorough questionnaire that examines the individual's stuttering experience is used to determine the severity of stuttering. This questionnaire is divided into four components that encompass the individual's experience: basic stuttering knowledge, stuttering reactions, communication in everyday situations, and quality of life. The questions are answered on a 5-point scale by the participant. The results of the tests are displayed in two dimensions: impact severity and impact level. The questionnaire results are organized into two categories: impact level and impact severity. The impact level is always between 20 and 100, and the severity of the impact is defined by this, ranging from mild to severe. Tehran University of Medical Sciences Approved 2023-09-05 Ethics Committee in Tehran University of Medical Sciences Intersection of Keshavarz Boulevard and Qods Street, Central Headquarters Building of Tehran University of Medical Sciences, 6th floor, Room 604, Ethics Committee Secretariat in the University's Research Ethics Office. Tehran Tehran Iran (Islamic Republic of)