Skip to content

The Effect of the Non-invasive Brain Stimulation on the Speech Fluency Enhancement

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03990168
Enrollment
50
Registered
2019-06-18
Start date
2019-10-01
Completion date
2020-04-01
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stuttering/ Developmental

Brief 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. 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.

Interventions

DEVICEAnodal tDCS

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.

BEHAVIORALfluency intervention/ Delayed Auditory Feedback

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.

DEVICESham tDCS

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.

Sponsors

Iran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean score of percentage of Stuttered Syllables produced in the speech sampleBaselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatmentResearcher will calculate the Percentage of Stuttered Syllables (SS %) in the speech sample. Lower percentage of Stuttered Syllables represents better outcomes.

Secondary

MeasureTime frameDescription
Mean score of the Stuttering Severity Instrument version 4 (SSI-4)Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatmentThe 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.
Mean score of the Overall Assessment of Speakers Experience of Stuttering (OASES)Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatmentThe 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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026