Stuttering/ Developmental Clinical Trial
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
| Verified date | November 2020 |
| Source | Iran University of Medical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | April 1, 2020 |
| Est. primary completion date | April 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility | Inclusion Criteria: - History of developmental stuttering - Participants diagnosed with moderate to severe stuttering - Right handed - Native speaker of Farsi Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | Narges Moin | Tehran |
| Lead Sponsor | Collaborator |
|---|---|
| Iran University of Medical Sciences |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment | |
| Secondary | 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. | Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment | |
| Secondary | 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. | Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment |