| CTRI Number |
CTRI/2025/03/083684 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of High-Definition Transcranial Direct Current Stimulation and Prolonged Speech Treatment in Kannada-Speaking Adults who Stutter |
|
Scientific Title of Study
|
Effect of High-Definition Transcranial Direct Current Stimulation and Prolonged Speech Treatment in Kannada-Speaking Adults who Stutter: A Treatment Comparison |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Audrey Joyner Dsouza |
| Designation |
Junior Research Fellow |
| Affiliation |
All India Institute of Speech and Hearing |
| Address |
All India Institute of Speech and Hearing, Manasagangothri, Mysore, India
Naimisham Campus, Manasagangothri, Mysore, India
Mysore
KARNATAKA
570006
India |
| Phone |
7204955226 |
| Fax |
|
| Email |
audreydsouza98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh M |
| Designation |
Professor |
| Affiliation |
All India Institute of Speech and Hearing |
| Address |
All India Institute of Speech and Hearing, Manasagangothri, Mysore, India
Naimisham Campus, Manasagangothri, Mysore, India
Mysore
KARNATAKA
570006
India |
| Phone |
9663922033 |
| Fax |
|
| Email |
santoshm79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Audrey Joyner Dsouza |
| Designation |
Junior Research Fellow |
| Affiliation |
All India Institute of Speech and Hearing |
| Address |
All India Institute of Speech and Hearing, Manasagangothri, Mysore, India
Naimisham Campus, Manasagangothri, Mysore, India
KARNATAKA
570006
India |
| Phone |
7204955226 |
| Fax |
|
| Email |
audreydsouza98@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Speech and Hearing, Manasagangothri, Mysore, Karnataka, India -570006 |
|
|
Primary Sponsor
|
| Name |
Audrey Joyner Dsouza |
| Address |
Centre of Speech Language Sciences, All India Institute of Speech and Hearing, Manasagangothri, Mysore |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| All India Institute of Speech and Hearing |
All India Institute of Speech and Hearing, Manasagangothri, Mysore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh M |
All India Institute of Speech and Hearing |
tDCS lab, Centre of Excellence for Speech Language Sciences
Mysore
KARNATAKA |
9663922033
santoshm79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, All India Institute of Speech and Hearing, Manasagangothri, Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F988||Other specified behavioral and emotional disorders with onset usually occurring in childhood and adolescence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Prolonged speech treatment |
Participant will be asked to prolong the initial syllable of the stuttered syllable. This will be carried out for 10 sessions. |
| Comparator Agent |
Sham Transcranial Direct Current Stimulation |
1mA current will be delivered for 1st 30 seconds and last 30 seconds of the 20 mins time framework for 10 days through AgCL sintered electrodes used in high-definition transcranial direct current stimulation along with choral speech during reading task. Five electrodes will be place among which the center electrode will be placed at FC5 approximating the left inferior frontal gyrus as per the combinatorial 10-20 system of EEG electrode placement. The other four electrodes will be placed on FC1, FT9, AF7 and CP5 respectively. The procedure for using HD-tDCS suggested by Villamar et al., (2013) will be followed. |
| Intervention |
Transcranial Direct Current STimulation |
1mA current will be delivered for 20 mins for 10 days through AgCL sintered electrodes used in high-definition transcranial direct current stimulation along with choral speech during reading task. Five electrodes will be place among which the center electrode will be placed at FC5 approximating the left inferior frontal gyrus as per the combinatorial 10-20 system of EEG electrode placement. The other four electrodes will be placed on FC1, FT9, AF7 and CP5 respectively. The procedure for using HD-tDCS suggested by Villamar et al., (2013) will be followed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with developmental stuttering by a speech-language pathologist; Minimum of mild severity of stuttering on stuttering severity instrument- fourth edition; Native Kannada speaker; Right-handed; Education qualification above 10th grade.
|
|
| ExclusionCriteria |
| Details |
Individuals who have undergone speech therapy for stuttering in the past 2 years; Has a history of any other speech, language, or neurological disorders; History of seizures; Family history of seizures; History of head injury/surgery; History of unexplained loss of consciousness; Pregnancy; Presence of metal implant, pacemakers, or any other implantable devices; History of frequent or severe headache or migraine; History of alcohol consumption in the past 15 days or history of any other substance abuse; History of usage of psychiatric medications such as antidepressants or antipsychotics; Intake of any medications anytime in the past 15 days, or during the course of the study; Presence of any illness that has an influence on the brain, during the study; Presence of skin allergies or wounds at the site of stimulation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of syllables stuttered |
Baseline assessment, post-10 sessions, 1 week post-treatment, and 1 month post-treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Self-rated stuttering severity, Stuttering Severity Instrument – fourth edition, Naturalness rating, Overall assessment of the speaker’s experience of stuttering for adults in Kannada, Communication attitude test in Kannada for adults who stutter, Unhelpful Thoughts and Beliefs About Stuttering Scales-6, Rate of speech |
Baseline assessment, post-10 sessions, 1 week post-treatment, and 1 month post-treatment |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/04/2026 |
| Date of Study Completion (India) |
09/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - On request to the investigators emailed to audreydsouza98@gmail.com, neccesary data can be shared.
- For how long will this data be available start date provided 09-12-2026 and end date provided 28-02-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study with a parallel group design will consist of three groups of adults who stutter. Group 1: receiving high-definition transcranial direct current stimulation (tDCS) for 20 mins; Group 2: receiving sham tDCS and Group 3: receiving prolonged speech treatment. All the treatment groups will have 10 sessions. The tDCS groups will receive 1mA for 20 minutes on the left inferior frontal gyrus while reading throughout the session with the clinician. The primary outcome measure will be the percentage of syllables stuttered during the reading, conversation and narration tasks. |