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

Iran University of Medical Sciences

Status: Completed

Conditions: Stuttering/ Developmental

Treatments: Behavioral: fluency intervention/ Delayed Auditory Feedback; Device: Anodal tDCS; Device: Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03990168

98-2-75-15001

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Experimental

Experimental group

Description:

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.

Treatment:

Behavioral: fluency intervention/ Delayed Auditory Feedback

Device: Anodal tDCS

Sham Comparator

Sham Comparator group

Description:

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.

Treatment:

Behavioral: fluency intervention/ Delayed Auditory Feedback

Device: Sham tDCS