Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278233
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-08
Brief Title:
Bihemispheric Transcranial Direct Current Stimulation on Speech Fluency
Sponsor:
Biruni University
Organization:
Biruni University
Study Overview
Official Title:
An Investigation of the Effect of 5 Consecutive Days of Bihemispheric TDCS on Speech Fluency in Individuals With Stuttering
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TDCS
Brief Summary:
It will be determined whether bihemispheric stimulation anodal to the left IFG and cathodal to the right IFG is used with fluency-facilitating conditions for 5 consecutive days in individuals with stuttering and whether there is a difference in terms of the effects seen in speech fluency compared to the sham condition
Detailed Description:
Developmental stuttering is a fluency disorder that can negatively affect many aspects of an individuals life Recent transcranial direct current stimulation tDCS studies with individuals with stuttering show that tDCS shows promise in increasing fluency when used in combination with situations that temporarily increase fluency In this study it was aimed to investigate the effect of bi-hemispheric tDCS on fluency in individuals with stuttering for 5 consecutive days The hypothesis of the study is that bi-hemispheric stimulation which includes anodal stimulation to the left hemisphere and cathodal stimulation to the right hemisphere will be effective on reading and speech fluency when performed for 5 consecutive days Thirty-six adults with developmental stuttering are expected to complete this double-blind sham-controlled study Participants will be divided into two groups by blocked randomization and one group will receive sham stimulation for 5 consecutive days and the other group will receive bihemispheric stimulation Participants in the tDCS group will receive 20 minutes of tDCS stimulation accompanied by metronome-timed speech during the practice sessions Reading and speaking fluency will be assessed immediately before immediately after and one week after the stimulation sessions Data will be collected using the stuttering severity assessment instrument SSI-4 Results will be compared both within and between groups in terms of percentage of stuttered syllables stuttering severity and evaluation of the speakers experience of stuttering
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None