| CTRI Number |
CTRI/2025/10/095516 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Mild electrical stimulation to brain for people with head and neck cancer who have swallowing difficulty |
|
Scientific Title of Study
|
Effect of transcranial direct current stimulation on dysphagia in patients with head and neck cancer - A randomized controlled trial |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samiksha ketkale |
| Designation |
PG student |
| Affiliation |
KLE institute of physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced physiotherapy center, Department of Neurophysiotherpy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
7972148476 |
| Fax |
|
| Email |
samiksha15ketkale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Samiksha ketkale |
| Designation |
PG student |
| Affiliation |
KLE institute of physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced physiotherapy center, Department of Neurophysiotherpy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
7972148476 |
| Fax |
|
| Email |
samiksha15ketkale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjiv Kumar |
| Designation |
Professor |
| Affiliation |
KLE institute of physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced physiotherapy center, Department of Neurophysiotherpy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar kore Hospital and Medical Research center belagavi, karnataka. 590010 |
|
|
Primary Sponsor
|
| Name |
Samiksha ketkale |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced physiotherapy center, Department of Neurophysiotherpy, Belgaum, Karnataka |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samiksha Ketkale |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi. |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room No. 39, Sagar Floor, Advanced Physiotherapy Centre, Department of Neurophysiotherapy, Belgaum, Karnataka.
Belgaum
KARNATAKA |
7972148476
samiksha15ketkale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham tDCS + Conventional exercises |
Training frequency- 5 sessions per week
Training duration- 20 minutes
Number of weeks- 2 weeks
Exercises- 30 minutes per session |
| Intervention |
tDCS + conventional exercises |
Training frequency- 5 sessions per week
Training duration- 20 minutes
Number of weeks- 2 weeks
Exercises- 30 minutes per session |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with head and neck cancer for the first time who is undergoing any cancer therapy treatment and suffering from dysphagia in the age group of 18-75 years of both gender and willing to participate.
2. EAT10 self-administered questionnaire score 3-15 (score more than 15 is more severe swallowing difficulty)
|
|
| ExclusionCriteria |
| Details |
1. Patient with cognitive impairment
2. Presence of implanted metal or electronic medical devices
3. Skin problems (e.g. dermatitis, psoriasis)
4. Patients who are on artificial feeding
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional oral intake scale |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dysphagia handicap index |
10 minutes |
| Dysphagia outcome severity scale |
10 minutes |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Effect of Transcranial Direct Current Stimulation on Dysphagia in Patients with Head and Neck Cancer – A Randomized Controlled Trial
This study addresses swallowing difficulties that commonly occur after cancer treatment, which can severely affect nutrition and quality of life. Since current therapies often fail to restore normal swallowing, there is a need to explore newer non-invasive brain stimulation methods like tDCS, which has shown promising results in neurogenic dysphagia but is less studied in cancer-related cases. The aim of this study is to evaluate the effect of tDCS on dysphagia in head and neck cancer patients, using scales such as FOIS, DHI, and DOSS. For this, 22 participants will be randomly assigned into two groups: one receiving tDCS with conventional exercises and the other receiving sham stimulation with conventional exercises. Assessments will be done before and after the intervention to compare outcome measures. |