| CTRI Number |
CTRI/2025/11/096938 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of tDCS on cognitive function in patients of Alzheimers Disease |
|
Scientific Title of Study
|
Study of Effectiveness of transcranial direct current stimulation (tDCS) on cognitive function in patients of Alzheimer's Disease: A double blind sham controlled randomized 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 |
Bhavikkumar Maheshbhai Patel |
| Designation |
Junior Resident Doctor |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL |
| Address |
Department of Psychiatry,
IMS and SUM Hospital Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9909992940 |
| Fax |
|
| Email |
dr.bhavik02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Suvendu Narayan Mishra |
| Designation |
Professor |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL |
| Address |
Department Of Psychiatry
IMS and Sum Hospital
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9861273580 |
| Fax |
|
| Email |
dr.sar07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Suvendu Narayan Mishra |
| Designation |
Professor |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL |
| Address |
Department Of Psychiatry
IMS and Sum Hospital
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9861273580 |
| Fax |
|
| Email |
dr.sar07@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
Department of Psychiatry, IMS and SUM Hospital
Kalinganagar
Bhubaneswar 751003 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Prof Dr Suvendu Narayan Mishra |
IMS AND SUM Hospital Bhubaneswar |
IMS AND SUM HOSPITAL
KALINGNAGAR
BHUBANESWAR 751003
Khordha
ORISSA |
9861273580
dr.sar07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G30||Alzheimers disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham (Placebo) Transcranial Direct current stimulation (tDCS) |
The Anode electrode and the cathode electrode will be placed over the left dorsolateral prefrontal cortex and over the right supraorbital area respectively.
Stimulation Parameters : Machine set to Sham Parameters.
Duration of session – 20 min
Total 10 Sessions for 5 days (twice daily) |
| Intervention |
Transcranial Direct current stimulation (tDCS) |
The Anode electrode and the cathode electrode will be placed over the left dorsolateral prefrontal cortex and over the right supraorbital area respectively.
Stimulation Parameters :
Current intensity – 2mA
Duration of session – 20 min
Total 10 Sessions for 5 days (twice daily) |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
A : Patients diagnosed with Alzheimer’s disease according to standardized diagnostic criteria (ICD-11).
B : Patients who will give informed consent.
C : Patients between the ages of 60 years and 80 years.
D : Patients on Donepezil for a minimum of 4 weeks with MMSE Score between 18-23.
|
|
| ExclusionCriteria |
| Details |
A : Age below 60 years and above 80 years
B : Patients with a history of significant neurological disorders other than dementia (e.g. Traumatic Head Injury, epilepsy).
C : Individuals with severe psychiatric conditions (e.g., schizophrenia, Mental retardation, Mood Disorders)
D : Individual who was previously diagnosed with Wernicke’s Koraskoff Psychosis
E : Those with contraindications to tDCS (transcranial direct current stimulation), such as implanted electronic devices.
F : Inability to undergo the required cognitive assessments due to language barriers, severe sensory impairments, or other factors affecting comprehension or communication. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of tDCS on cognitive function in patients of alzheimers disease
Scales : ACE-III,MMSE,CGI and side effects |
At Baseline, after 4 weeks [total 40 sessions (twice daily 5 days per week x 4 week)] and after 8 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 2 |
|
Date of First Enrollment (India)
|
17/11/2025 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Purpose of this study is it will be one of the first studies
to evaluate tDCS(transcranial direct current stimulation) in AD(Alzheimer’s Disease) patients in Odisha using a
double-blind, sham-controlled design. Addressing population-specific factors,
it provides novel insights into tDCS’s applicability in Indian contexts,
guiding future clinical and policy decisions.
Hypothesis: Active tDCS
improves cognitive function in AD patients compared to sham tDCS,
with negligible adverse effects. |