| CTRI Number |
CTRI/2025/03/082070 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [TRANSCRANIAL DIRECT CURRENT STIMULATION FOR COGNITIVE IMPROVEMENT] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Transcranial direct current stimulation for cognitive improvement in Primary Open angle individuals. |
|
Scientific Title of Study
|
TO EVALUATE EFFECTIVENESS OF TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) FOR IMPROVING COGNITIVE FUNCTION IN PRIMARY OPEN ANGLE GLAUCOMA (POAG) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TANUJ DADA |
| Designation |
PROFESSOR |
| Affiliation |
DR R.P CENTRE OF OPHTHALMIC SCIENCES NEW DELHI |
| Address |
ROOM 485 , RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES NEW DELHI 110029
New Delhi
DELHI
110029
India |
| Phone |
9873336315 |
| Fax |
|
| Email |
tanujdada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
TANUJ DADA |
| Designation |
PROFESSOR |
| Affiliation |
DR R.P CENTRE OF OPHTHALMIC SCIENCES NEW DELHI |
| Address |
ROOM 485 , RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES NEW DELHI 110029
New Delhi
DELHI
110029
India |
| Phone |
9873336315 |
| Fax |
|
| Email |
tanujdada@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DIKSHA SINGHAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr R.P CENTRE OF OPHTHALMIC SCIENCES AIIMS NEW DELHI |
| Address |
ROOM 614
PATANJALI HOSTEL 19 MASJID MODH ROAD AIIMS CAMPUS
New Delhi
DELHI
110029
India |
| Phone |
8979840105 |
| Fax |
|
| Email |
diksha.singhal2014@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RAJENDRA PRASAD INSTITUTE OF OPHTHALMIC SCIENCES AIIMS |
| Address |
RAJENDRA PRASAD INSTITUTE OF OPHTHALMIC SCIENCES AIIMS NEW DELHI |
| Type of Sponsor |
Government medical college |
|
|
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 DIKSHA SINGHAL |
AIIMS NEW DELHI |
WARD , RAJENDRA PRASAD INSTITUTE OF OPHTHALMIC SCIENCES AIIMS NEW DELHI
A 115 1ST FLOOR NEW RAJKUMARI OPD
New Delhi
DELHI |
8979840105
diksha.singhal2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF ETHICS COMITTEE AIIMS OT BLOCK ANSARI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Anti Glaucoma Medications and Placebo |
Patients in Group 2 would recieve placebo (no transcranial direct current stimulation) along with standard anti glaucom medication |
| Intervention |
TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) |
tDCS(trans cranial direct current stimulation ) - 2mA of current will be delivered to left dorsolateral prefrontal cortex (DLPFC) for 20 min in a single session with Anode at Left DLPFC and Cathode at Right DLPFC placed.
20 sessions will be delivered consecutively over 10 days (5 days a week from Monday to Friday each week)
Inter-session interval on a day would be at least 3 hours
Anti glaucoma medication will be continued
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of POAG
Age more than 40 years
BCVA more than 6 by 12 in both eyes
Literate, educated up to 5th standard
Willing to participate in study
|
|
| ExclusionCriteria |
| Details |
Patients with other forms of glaucoma
Age less than 40 years
BCVA less than 6 by 12 in either eye
Eye disease other than glaucoma that could have affected RNFL and GC-IPL thickness, such as macular degeneration and optic neuropathy
Patients on systemic medications which could affect cognition example BZPs, Opiates, TCAs, Anticonvulsants and Dopamine agonists.
Patients with diagnosed neurological or psychiatric disease.
Patients with chronic systemic disease such as Diabetes, Coronary Artery Disease or Cerebrovascular Disease
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in cognitive functioning after tDCS in individuals with Primary Open Angle Glaucoma (POAG) |
At baseline and follow up at 1 month and 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To evaluate the association of cognitive functioning in POAG with Quality of life using EuroQol (EQ-5D-5L)
• To evaluate the association of cognitive functioning in POAG with
• Retinal nerve fiber layer (RNFL) and Ganglion cell layer (GCC) on Optical Coherence Tomography(OCT)
• Visual field sensitivity on Automated Perimetry
• Endogenous cortisol levels
|
At baseline and follow up at 1 month and 3 month |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/03/2025 |
| 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
|
•
Individuals with Primary open angle glaucoma (POAG)
may experience a heterogeneous set of visual and cognitive impairment,
progressively deteriorating their quality of life
•
Addressing cognitive
deficits could improve outcomes in POAG.
•
Transcranial direct current stimulation (tDCS) has
shown promise in improving cognitive dysfunction in Neurocognitive disorders (NCDs).
Since POAG has similar cognitive dysfunction as NCDs, tDCS may be a valuable
tool to manage such cognitive dysfunction in these individuals.
. Patient Assessments (a) General Physical Examination: (b) Systemic examination: (c) Ocular examination: -
Best Corrected Visual acuity using ETDRS and Snellen’s
chart -
Baseline IOP using NCT -
Stereoscopic fundus evaluation -
Ophthalmic Investigations: -
HVF 30-2 SITA Standard for Visual Field Analysis -
Retinal nerve
fiber layer Optical Coherence Tomography (RNFL OCT) -
Ganglion cell complex Optical Coherence
Tomography (GCC OCT) -
Disc photographs (d) Cognitive evaluation tests -
Addenbrooke
Cognitive examination – for Comprehensive Cognitive evaluation -
Functional Near
Infrared Spectroscopy (fNIRS) - Oxygenated
Hemoglobin (OxyHb) concentration change Total time for administration of cognitive tests = 30
minutes/patient (e) Pharmacological test -
Serum cortisol levels – 9 AM to 10 AM
(f) Quality of life assessment using EuroQol (EQ-5D-5L)
|