| CTRI Number |
CTRI/2025/07/090742 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to improve speech in people after stroke using brain stimulation and speech therapy |
|
Scientific Title of Study
|
Transcranial direct current stimulation (tDCS): An adjunct to conventional speech and language therapy in persons with aphasia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swathi Chinnasamy |
| Designation |
Ph.D Scholar |
| Affiliation |
All India Institute of Speech and Hearing |
| Address |
All India Institute of Speech and Hearing,
Naimisham Campus, Road No.3, T K Layout, Manasagangothri, Mysuru
Mysore
KARNATAKA
570006
India |
| Phone |
7598282365 |
| Fax |
91-0821-2510515 |
| Email |
swathicslp2023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyapal Puri Goswami |
| Designation |
Professor in Speech Pathology |
| Affiliation |
All India Institute of Speech and Hearing |
| Address |
All India Institute of Speech and Hearing,
Naimisham Campus, Road No.3, T K Layout, Manasagangothri, Mysuru
Mysore
KARNATAKA
570006
India |
| Phone |
9480169216 |
| Fax |
|
| Email |
goswami16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swathi Chinnasamy |
| Designation |
Ph.D Scholar |
| Affiliation |
All India Institute of Speech and Hearing |
| Address |
All India Institute of Speech and Hearing,
Naimisham Campus, Road No.3, T K Layout, Manasagangothri, Mysuru
Mysore
KARNATAKA
570006
India |
| Phone |
7598282365 |
| Fax |
|
| Email |
swathicslp2023@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Speech and Language Disorders in Children, Adults and Senior Citizens. All India Institute of Speech and Hearing,Naimisham Campus, Road No.3, T K Layout, Manasagangothri, Mysuru, Karnataka 570006 |
|
|
Primary Sponsor
|
| Name |
Ms Swathi Chinnasamy |
| Address |
Centre for Speech and Language Disorders in Children, Adults and Senior Citizens. All India Institute of Speech and Hearing,Naimisham Campus, Road No.3, T K Layout, Manasagangothri, Mysuru, Karnataka 570006 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Satyapal Puri Goswami |
Centre for Speech and Language Disorders in Children, Adults and Senior Citizens. All India Institute of Speech and Hearing,Naimisham Campus, Road No.3, T K Layout, Manasagangothri, Mysuru, Karnataka 570006 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Satypal Puri Goswami |
All India Institute of Speech and Hearing |
Centre of Excellence in Speech Language Sciences, Centre of Excellence, All India Institute of Speech and Hearing Naimisham Campus, Road No.3, T K Layout, Manasagangothri, Mysuru, Karnataka 570006
Mysore
KARNATAKA |
9480169216
goswami16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Review Board (IRB) Approval for Bio- Behavioural Research Proposal Involving Human Subjects at AIISH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I693||Sequelae of cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active transcranial direct current stimulation combined with speech and language therapy |
Stimulation intensity: 1mA; Stimulation duration:20 mins; Total duration of therapy: 1 hour; The person would receive active 20 minutes of stimulation combined with speech and language therapy for first 20 minutes follwed by only speech and language therapy alone for remaining 40 minutes.Course of treatment: 15 days |
| Comparator Agent |
Placebo transcranial direct current stimulation combined with speech and language therapy |
Stimulation intensity: 1mA; Stimulation duration:20 mins; Total duration of therapy: 1 hour; The person would receive 30 seconds of stimulation at the starting and ending of 20 minutes stimulation to have a placebo effect. Speech and language therapy will be continued for total 1 hour. Course of treatment: 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Greater than 18 years of age
2. Left hemisphere infarct
3. Premorbid right-handedness
4. Minimum of primary education
5. Premorbid Kannada speaker
6. Normal or corrected vision and hearing
7. Post-stroke duration greater than three months
8. Comprehension score greater than 4 in
Western Aphasia Battery- Kannada
|
|
| ExclusionCriteria |
| Details |
1. A history of any other neurological and psychiatric issues other than cerebrovascular accidents
2. A history of severe head injury
3. A history of seizures
4. A history of severe respiratory issues
5. A history of skin allergy or disease
6. Presence of any pacemaker or metal implant
7. History of migraine or frequent headaches
8. History of head surgery
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Western Aphasia Battery- Kannada |
1st day; 15th day; 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Boston naming test in Bilinguals |
1st day; 15th day; 30th day |
| Action Naming test (Kannada) |
1st day; 15th day; 30th day |
| Response scores of various subdomains of MAAT-K |
1st day; 15th day; 30th day |
| Communicative Effectiveness Index (CETI) |
1st day; 15th day; 30th day |
| Stroke and Aphasia Quality of Life Scale- 39 ( SAQOL-39) |
1st day; 15th day; 30th day |
| Life Satisfaction questionnaire (LISAT -K) |
1st day; 15th day; 30th day |
| Self and proxy-rated communication skills questionnaire |
1st day; 15th day; 30th day |
| tDCS Perspective questionnaire |
1st day; 15th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study is a single-centre, randomized, parallel-group, double-blinded study that aims to find the effectiveness of transcranial Direct Current Stimulation (tDCS) combined with conventional Speech and Language Therapy (SLT) in Persons with Aphasia. The primary outcomes are language performances of persons with aphasia and secondary outcomes are improvement in quality of life and life satisfaction. |