Protocol summary
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Study aim
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Determining the effect of a combined treatment of speech fluency shaping and transcranial direct current stimulation on improving speech fluency in adults with stuttering
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Design
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The Phase 3 clinical experiment is a randomized, double-blind, two-arm controlled trial with 62 adult stuttering participants.Participants will be assigned to one of two groups: anodal tDCS or sham tDCS. The website www.randomization.com will be used to develop a computer-generated randomization method. Each participant will be assigned to one of the experimental groups and given a unique ID.
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Settings and conduct
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Speech fluency shaping and transcranial direct current stimulation (tDCS) are used in the intervention, which is carried out in two stages over a three-week period at Tehran University of Medical Sciences' School of Rehabilitation Sciences.This study is double-blind . Neither the participants nor the investigators know which group (anodal or sham) each participant
is assigned to.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:1)Range of ages between 15 and 50 2)Right-handed 3)History of developmental stuttering with mild to very severe stuttering Exclusion criteria:1)Other speech and language impairements/cognitive or psychological diseases,attention deficit hyperactivity disorder(ADHD),brain surgery or tumors may coexist with stuttering 2)History of seizures 3)Intake of any medication that effects central nervous system function such as antiseizures and antidepression
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Intervention groups
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Participants will be randomized to one of two groups at random: intervention or control. Speech therapy will be combined with anodal transcranial direct current stimulation in the intervention group, whereas sham transcranial direct current stimulation will be used in the control group.
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Main outcome variables
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Percentage of stuttered syllables
General information
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Reason for update
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The implementation of this project began in December 2022, but due to the lengthy therapy sessions of the project's participants and the long follow-up process of these participants up to 3 months, as well as a sample size of 62 patients, more time is needed to complete the sampling process. Therefore, the completion date of the sampling process has been revised
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230907059369N1
Registration date:
2023-12-05, 1402/09/14
Registration timing:
prospective
Last update:
2025-07-15, 1404/04/24
Update count:
2
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Registration date
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2023-12-05, 1402/09/14
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2023-12-10, 1402/09/19
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Expected recruitment end date
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2026-10-21, 1405/07/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Investigation of the effect of the transcranial Direct Current Stimulation(tDCS) for improvement of speech fluency in adults who stutter
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
62
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-09-05, 1402/06/14
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1402.318
Health conditions studied
1
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Description of health condition studied
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Developmental stuttering
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ICD-10 code
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F80
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ICD-10 code description
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Specific developmental disorders of speech and language
Primary outcomes
1
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Description
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Percentage of stuttered syllables
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Timepoint
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One week prior to the intervention, Immediately after the intervention, 6 weeks after the intervention, and 12 weeks after the intervention
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Method of measurement
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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.
2
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Description
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Speech Naturalness
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Timepoint
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One week prior to the intervention, immediately after the intervention, 6 weeks after the intervention, and 12 weeks after the intervention
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Method of measurement
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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
3
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Description
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Severity rating
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Timepoint
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One week prior to the intervention, immediately after the intervention, 6 weeks after the intervention, and 12 weeks after the intervention
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Method of measurement
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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.
Secondary outcomes
1
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Description
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The severity of stuttering based on Severity Stuttering Instrument version-4
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Timepoint
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One week prior to the intervention and 12 weeks after the intervention
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Method of measurement
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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.
2
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Description
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The severity of stuttering based on Overall Assessment of the Speaker's Experience of Stuttering
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Timepoint
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One week prior to the intervention and 12 weeks after the intervention
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Method of measurement
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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.
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable