| CTRI Number |
CTRI/2025/09/094250 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of transcranial direct current stimulation on older adults with mild cognitive impairment |
|
Scientific Title of Study
|
Effect of transcranial direct current stimulation (tDCS) on cognitive function in older adults with mild cognitive impairment: a randomized, controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shashank Saurabh Sinha |
| Designation |
Asst Professor |
| Affiliation |
King george medical University |
| Address |
Deptt of Geriatric Mental Health
KGMU
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8287188508 |
| Fax |
|
| Email |
shashanksinha3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shashank Saurabh Sinha |
| Designation |
Asst Professor |
| Affiliation |
King george medical University |
| Address |
Deptt of Geriatric Mental Health
KGMU
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8287188508 |
| Fax |
|
| Email |
shashanksinha3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shashank Saurabh Sinha |
| Designation |
Asst Professor |
| Affiliation |
King george medical University |
| Address |
Deptt of Geriatric Mental Health
KGMU
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8287188508 |
| Fax |
|
| Email |
shashanksinha3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Geriatric Mental Health King Georges medical University Shah Mina Road Chowk Lucknow Uttar Pradesh India Pin 226003 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| 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 Shashank |
Gandhi Memorial and Associated hospital, |
Dr Shashank, OPD room No2, Ground floor, Department of Geriatric Mental Health,
King Georges Medical University
Lucknow
UTTAR PRADESH |
8287188508
shashanksinha3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King georges Medical University UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F06||Other mental disorders due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active transcranial direct current stimulation |
Group A will receive active tDCS (current intensity of 2 mA for 20 minutes with a ramp period of 10 seconds. A total of 10 sessions of active tDCS will be delivered over a period of two weeks following a uniform treatment protocol. |
| Comparator Agent |
SHAM tDCS (transcranial direct current stimulation) |
Participants of group B would be delivered a total of 10 sessions of sham tDCS over a period of two weeks following a uniform treatment protocol. |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Willingness to participate in the study
2 Age 55 years and above
3 Diagnosed with Mild Neurocognitive disorder as per DSM5 criteria
|
|
| ExclusionCriteria |
| Details |
1 Uncooperative patients or sensory deficits making assessment difficult
2 Refusal to give written informed consent for participation in the study and tDCS application
3 Medical comorbidities that need immediate attention or patients with terminal illness
4 Family or personal history of epilepsy
5 Any contraindication to tDCS such as History of Head injury or Implanted medical devices or Foreign body in head or eye
6 Scalp Injuries or Skin lesions
7 Presence of psychotic symptoms or suicidal ideations
8 Patients currently in Depression with HAMD score greater than 8 or in Delirium
9 Any other psychiatric comorbidity with exception to tobacco use disorder
10 Patients on procognitive drugs like donepezil or memantine etcectra
11 Current use of other neurostimulation treatments
12 Participants with abnormal thyroid function test or serum Vit B 12 level or Vit D3 level
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in cognitive function assessed by ACE-H |
At End of 1st week, 2nd week, 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- ACE-H (total score)
-Change in well-being WHO-Qol-Brief score
-Side effect of tDCS
|
At End of 1st week, 2nd week, 3rd week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/10/2025 |
| 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="0"
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 - 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 - 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to shashanksinha3@gmail.com
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A hospital-based, interventional study has been planned as part of this research endeavor. A randomized controlled study would be conducted at Department of Geriatric Mental Health and Department of Psychiatry of a tertiary care hospital of North India. Approval from the Institutional Ethics Committee (IEC) has been received. Adults above 55 years of age qualifying the DSM-5 criteria for Mild neurocognitive disorder will be approached and requested to take part in the study as per study inclusion/ exclusion criteria. The sample size for this study was calculated as 32. Assuming a dropout of 20% the sample size for entire study was estimated as 40. The sample for the study would be identified using purposive sampling technique. The participants would be randomly allocated into two groups based on which there will be single blinding as the participants would not be aware of the allocation. Participants of group A will receive active tDCS (current intensity of 2 mA for 20 minutes with a ramp period of 10 seconds. A total of 10 sessions of active tDCS will be delivered over a period of two weeks following a uniform treatment protocol. Similarly, participants of group B would be delivered a total of 10 sessions of sham tDCS over a period of two weeks following a uniform treatment protocol. Addenbrooke cognitive examination (Hindi version) and WHO-Quality of life scale (brief version) would be applied at baseline and at end of 2nd week and 3rd week. tDCS check list will be applied for monitoring side effects after each tDCS sessions. In case the patient develops any minor adverse effects due to tDCS, conservative management will be done, and patient will be reassured. The study will determine whether tDCS enhances cognitive function and quality of life in older adults with mild NCD,
|