Stuttering/ DevelopmentalNCT03990168
The Effect of the Non-invasive Brain Stimulation on the Speech Fluency Enhancement
A study testing Anodal tDCS and fluency intervention/ Delayed Auditory Feedback in people with Stuttering/ Developmental, run by Iran University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to determine the effectiveness of concurrent transcranial direct current stimulation (tDCS) and fluency training in adults with developmental stuttering. We examine the severity of stuttering to investigate the effect of treatnment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Stuttering/ Developmental
- What is being tested?
- Anodal tDCS and fluency intervention/ Delayed Auditory Feedback
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 1 Oct 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of developmental stuttering
- Participants diagnosed with moderate to severe stuttering
- Right handed
- Native speaker of Farsi
Who cannot join
- Speech or language disorders other than stuttering
- Received stuttering treatment within the past year
- Hearing loss
- History of neurological or psychiatric disorders
- History of seizure
- Taking any medication that may affect brain function such as anti-depressants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Combined Treatment Approach of Delayed Auditory Feedback and Transcranial Direct Current Stimulation to Enhancement of Speech Fluency in Adults Who Stutter
The aim of this study is to determine the effectiveness of concurrent transcranial direct current stimulation (tDCS) and fluency training in adults with developmental stuttering. We examine the severity of stuttering to investigate the effect of treatnment. In the control group the anodal tDCS and DAF will applied on six consecutive days (1 milliampere [mA] for 20 mins per day), and the control group will received the sham stimulation and DAF for the same time. The severity of stuttering measured by means of tasks and questionnaires before and after treatment sessions and 6 weeks after intervention.
- Conditions
- Stuttering/ Developmental
- Being tested
- Anodal tDCS, fluency intervention/ Delayed Auditory Feedback, Sham tDCS
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
1 mA anodal tDCS positioned over left superior temporal gyrus and the cathode placed over the occipital lobe. The tDCS stimulation will be delivered for 20 minutes on 6 intervention days.
fluency intervention/ Delayed Auditory FeedbackBehavioural
Each participant complete three tasks include reading, conversation, and narration. Delayed auditory feedback will be used during these tasks. Each treatment session will take 20 minutes.
Sham tDCSDevice
The anodal tDCS positioned over left superior temporal gyrus and the cathode placed over the occipital lobe. The current of sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes on 6 intervention days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will receive one anodal tDCS at 1 mA intensity over the left superior temporal gyrus (T3 in 10-20 international system) and the cathode tDCS over the right orbitofrontal area (Fp2 in 10-20 international system). tDCS will be delivered for 20 minutes during fluency intervention for six consecutive days. Receives: Device: Anodal tDCS; Behavioral: fluency intervention/ Delayed Auditory Feedback |
| Sham Comparator | Sham comparator | Participants will receive sham tDCS while the one anode electrode will be positioned over the left superior temporal gyrus and the cathode will be placed over the right orbitofrontal similar to the active mode. The sham stimulation will break down after 30 seconds at the beginning of 20 minutes of fluency intervention for six consecutive days. Receives: Behavioral: fluency intervention/ Delayed Auditory Feedback; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean score of percentage of Stuttered Syllables produced in the speech sample
Researcher will calculate the Percentage of Stuttered Syllables (SS %) in the speech sample. Lower percentage of Stuttered Syllables represents better outcomes.
Measured: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Secondary outcomes (2)
Mean score of the Stuttering Severity Instrument version 4 (SSI-4)
The Stuttering Severity Instrument (SSI-4) is a standardized measure of stuttering severity consist of of 3 subscales (frequency, duration and physical concomitants) which are summed to give a total score. The maximum total score of the SSI-4 is 56, which corresponds to the highest stuttering severity. So, lower score represents better outcomes.
Measured: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Mean score of the Overall Assessment of Speakers Experience of Stuttering (OASES)
The OASES is a standardized assessment to measure the effect of stuttering on a person's life that consists of 4 subscales (general information about speech, your reactions to stuttering, communication in daily situations, quality of life). Each sub-test has a score from 1 to 5 in which the number 1 indicates the least negative impact and number 5 shows the most negative impact. These are combined to give a total impact score between 1 and 5, with 5 representing the highest negative impact on person's life. So, higher score represents better outcomes.
Measured: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Oct 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stuttering/ DevelopmentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moin, Iran University of Medical Sciences
- Investigators
- Reyhane Mohamadi, Study director, Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990168
- Sponsor's protocol ID
- 98-2-75-15001
- Status last verified
- Nov 2020
- First submitted
- 14 Jun 2019
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moein N, Mohamadi R, Rostami R, Nitsche M, Zomorrodi R, Ostadi A, Keshtkar A. Delayed Auditory Feedback and Transcranial Direct Current Stimulation Treatment for the Enhancement of Speech Fluency in Adults Who Stutter: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Apr 21;9(4):e16646. doi: 10.2196/16646.
PubMed 32314973
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Combined Treatment Approach of Delayed Auditory Feedback and Transcranial Direct Current Stimulation to Enhancement of Speech Fluency in Adults Who Stutter
- ClinicalTrials.gov ID
- NCT03990168
- Acronym / sponsor ID
- 98-2-75-15001
- Conditions
- Stuttering/ Developmental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effectiveness of concurrent transcranial direct current stimulation (tDCS) and fluency training in adults with developmental stuttering. We examine the severity of stuttering to investigate the effect of treatnment. In the control group the anodal tDCS and DAF will applied on six consecutive days (1 milliampere [mA] for 20 mins per day), and the control group will received the sham stimulation and DAF for the same time. The severity of stuttering measured by means of tasks and questionnaires before and after treatment sessions and 6 weeks after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Anodal tDCS, Behavioral: fluency intervention/ Delayed Auditory FeedbackParticipants will receive one anodal tDCS at 1 mA intensity over the left superior temporal gyrus (T3 in 10-20 international system) and the cathode tDCS over the right orbitofrontal area (Fp2 in 10-20 international system). tDCS will be delivered for 20 minutes during fluency intervention for six consecutive days. |
| Sham Comparator | Sham comparator | Behavioral: fluency intervention/ Delayed Auditory Feedback, Device: Sham tDCSParticipants will receive sham tDCS while the one anode electrode will be positioned over the left superior temporal gyrus and the cathode will be placed over the right orbitofrontal similar to the active mode. The sham stimulation will break down after 30 seconds at the beginning of 20 minutes of fluency intervention for six consecutive days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of developmental stuttering
- Participants diagnosed with moderate to severe stuttering
- Right handed
- Native speaker of Farsi
Key exclusion criteria (6 listed)
- Speech or language disorders other than stuttering
- Received stuttering treatment within the past year
- Hearing loss
- History of neurological or psychiatric disorders
- History of seizure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal tDCS1 mA anodal tDCS positioned over left superior temporal gyrus and the cathode placed over the occipital lobe. The tDCS stimulation will be delivered for 20 minutes on 6 intervention days. | Device | Experimental |
| fluency intervention/ Delayed Auditory FeedbackEach participant complete three tasks include reading, conversation, and narration. Delayed auditory feedback will be used during these tasks. Each treatment session will take 20 minutes. | Behavioural | Experimental, Sham Comparator |
| Sham tDCSThe anodal tDCS positioned over left superior temporal gyrus and the cathode placed over the occipital lobe. The current of sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes on 6 intervention days. | Device | Sham Comparator |
Primary outcome
Mean score of percentage of Stuttered Syllables produced in the speech sample
Time frame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Researcher will calculate the Percentage of Stuttered Syllables (SS %) in the speech sample. Lower percentage of Stuttered Syllables represents better outcomes.
2 secondary outcomes
Mean score of the Stuttering Severity Instrument version 4 (SSI-4)
Time frame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Mean score of the Overall Assessment of Speakers Experience of Stuttering (OASES)
Time frame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 32314973Moein N, Mohamadi R, Rostami R, Nitsche M, Zomorrodi R, Ostadi A, Keshtkar A. Delayed Auditory Feedback and Transcranial Direct Current Stimulation Treatment for the Enhancement of Speech Fluency in Adults Who Stutter: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Apr 21;9(4):e16646. doi: 10.2196/16646.
- Individual participant dataSharing planned: Undecided
Related trials for Stuttering/ Developmental
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Noninvasive Thalamocortical Neuromodulation With Low-Intensity Focused Ultrasound for Persistent Developmental Stuttering
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reyhane Mohamadi study director
Iran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS and fluency intervention/ Delayed Auditory Feedback in people with Stuttering/ Developmental, run by Iran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score of percentage of Stuttered Syllables produced in the speech sample (time frame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03990168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.