| CTRI Number |
CTRI/2025/06/089128 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
08/06/2025 |
| 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
|
A study evaluating the effect of brain stimulation treatment on improving memory and thinking in individuals with moderate to severe head injuries, compared to a similar group not receiving the treatment |
|
Scientific Title of Study
|
A DOUBLE-BLIND RANDOMIZED SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND TOLERABILITY OF HIGH DEFINITION TRANSCRANIAL DIRECT CURRENT STIMULATION (HD-tDCS) ON COGNITIVE FUNCTIONING IN MODERATE TO SEVERE TRAUMATIC BRAIN INJURY (TBI) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JAY MALYA BANERJEE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
DEPARTMENT OF PSYCHIATRY, AIIMS NEW DELHI, ANSARI NAGAR EAST
New Delhi
DELHI
110029
India |
| Phone |
9310957202 |
| Fax |
|
| Email |
malyajoy11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ROHIT VERMA |
| Designation |
PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
DEPARTMENT OF PSYCHIATRY, ROOM NO 4095, TEACHING BLOCK, AIIMS NEW DELHI, ANSARI NAGAR EAST
New Delhi
DELHI
110029
India |
| Phone |
9868005491 |
| Fax |
|
| Email |
rohit.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ROHIT VERMA |
| Designation |
PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
DEPARTMENT OF PSYCHIATRY, ROOM NO 4095, TEACHING BLOCK, AIIMS NEW DELHI, ANSARI NAGAR EAST
DELHI
110029
India |
| Phone |
9868005491 |
| Fax |
|
| Email |
rohit.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
DEPARTMENT OF PSYCHIATRY, AIIMS, NEW DELHI, ANSARI NAGAR EAST 110029 |
| 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 JAY MALYA BANERJEE |
All India Institute of Medical Sciences, New Delhi |
DEPARTMENT OF PSYCHIATRY, ROOM NO 4096, 4TH FLOOR, TEACHING BLOCK, AIIMS, ANSARI NAGAR, NEW DELHI 110029
New Delhi
DELHI |
9310957202
malyajoy11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POSTGRADUATE RESEARCH, AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S063||Focal traumatic brain injury, (2) ICD-10 Condition: S062||Diffuse traumatic brain injury, (3) ICD-10 Condition: S061||Traumatic cerebral edema, (4) ICD-10 Condition: S064||Epidural hemorrhage, (5) ICD-10 Condition: S065||Traumatic subdural hemorrhage, (6) ICD-10 Condition: S066||Traumatic subarachnoid hemorrhage, (7) ICD-10 Condition: S068||Other specified intracranial injuries, (8) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HIGH DEFINITION TRANSCRANIAL DIRECT CURRENT STIMULATION (HD-tDCS) |
20 SESSIONS OF HD-tDCS ( 2 SESSIONS PER DAY WITH INTERVAL OF 3 HOURS BETWEEN EACH SESSION PER DAY) |
| Comparator Agent |
SHAM TRIAL |
20 SESSIONS OF SHAM (PLACEBO TRIAL) ( 2 SESSIONS PER DAY WITH INTERVAL OF 3 HOURS BETWEEN EACH SESSION PER DAY) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.18-45 years of age
2.Any gender
3.Right handed individual
4.Participants who can read Hindi OR English language
5.History of Head injury (TBI)
6.Time Since Injury should be more than 6 months since TBI (chronic
TBI)
7.History of Moderate to Severe TBI (Mayo TBI
severity classification system)
8.Presence of at least one cognitive symptom on the
Neurobehavioral Symptom Inventory (NS I)
|
|
| ExclusionCriteria |
| Details |
1.Individuals with Compound skull fracture
2.History of neurological or psychiatric illness prior to TBI in individuals.
3.Substance dependence with in previous 6 months
(except Nicotine and Caffeine)
4.Presence of implanted electrical devices or any
skull discontinuity over targeted brain regions
5.Post traumatic aphasia or psychosis or hydrocephalus or
vision loss or upper limb weakness
6.Individuals who are currently pregnant or lactating
7.Presence of uncontrolled medical illness
8.History of receiving any neuromodulation therapy
(CES, ECT, rTMS, tDCS) in previous 6 months
9.Currently undergoing Cognitive
Rehabilitation Training
10.Recent changes in psychotropic medications
(within previous 2 months)
11.Deny written informed consent (patient and
LAR or NR) OR Uncooperative |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in cognitive functioning in moderate to
severe TBI and to assess any adverse effcct due to tDCS
intervention in moderate-severe TBI (within both active and sham group) |
At baseline and after 10 sessions and after 20 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in qEEG (spectral power density for slow frequencies) and fNlRS
(OxyHb changes) after tDCS in moderate to severe TBI (within both active and sham groups) |
At baseline and after 10 sessions and after 20 sessions |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/07/2025 |
| 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="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
|
Worldwide, there is high prevalence of Traumatic
Brain Injury (TBI) and of individuals who are
struggling with persistent TBI-related cognitive
deficits. Pharmacological treatment strategies
to
manage these cognitive deficits are limited by
effectiveness as well as tolerability Issues. Only
cognitive training is available at present, however it
is often time consuming and ineffective.
Synaptic plasticity has been a good prognostic factor
for patients who have suffered Traumatic Brain
Injury. Transcranial Direct Current Stimulation
(tDCS) is a form of cheaper, safer, and feasible
method and literature has reported its effectiveness in
improving synaptic plasticity. However there has
been a paucity of studies both worldwide as well as
in
India which investigates the utility of tDCS for
cognitive impairment after TBI. Consultants and Senior Residents in the outpatient department (OPD) of Psychiatry, Neuropsychiatry,
Neurosurgery, Trauma Psychiatry and at tDCS Facility of AIIMS, New Delhi shall be requested to refer
all the patients with chronic TBI (more than 6m since TBI). Out of the referred patients, those of 18-45 years of
age, right-handed, and with moderate to severe TBI (as per Mayo TBI severity classification system)
with at least one cognitive symptom on the NSI will be chosen by a purposive method for participation
in the study. Diagnosis of moderate to severe TBI will be confirmed using the Mayo TBI severity
classification and participants fulfilling the inclusion and exclusion criteria will be recruited. Participants
will be screened for psychiatric comorbidities using clinical interview. Physical, neurological and
substance use comorbidity as well as pregnancy or lactation will be ruled out by history and clinical
examination. Written consent will be taken prior to participation in the study.
After conducting the semi-structured interview and collecting the clinical data and examining the patient
for recruitment, participants will be allocated into 2 groups – one which will receive Active HD-tDCS
and another which will receive Sham HD-tDCS. Allocation concealment and double blinding will be
done to prevent selection bias and observer bias. For participant blinding, computer generated block
randomization list will be prepared by the guide for grouping participants into 2 groups (active tDCS or
sham tDCS) mentioning alphanumeric code for consecutive recruitment. Investigator after recruiting,
will send the participant to tDCS Facility with the alphanumeric code. For investigator blinding, the
technician will be allocating the participant to protocol A-tDCS or B-tDCS. Investigator will not be
informed whether the participant receives protocol A-tDCS or B-tDCS. For technician blinding, the
technician would be unaware of the interim protocol details. The protocols (A-tDCS or B-tDCS) would
be prepared by the guide.
A total of 20 sessions of active or sham HD-tDCS would be provided to each participant in respective
groups. Gaps between sessions would be allowed (24-48 hours) but if a participant misses 3 consecutive
days, then the participant would be considered drop out. Participants would keep receiving the
medications as prescribed by the treating clinician without any alteration during the study period and a
record of it would be made.
For both the groups baseline assessment/pre intervention assessment (ACE-III, TMTApp, qEEG,
fNIRS, CGI, WHODAS 2.0, NSI, tSEC) will be done within 2 days of assessments by sociodemographic
and clinical data using semi structured datasheet. And following that both groups will be called for 10
sessions of tDCS (2 sessions per day for the next 5 days). After completion of 10 sessions by both
groups, a mid-intervention assessment will be done for both groups using TMTApp, qEEG, CGI,
WHODAS 2.0, NSI, tSEC. The participants of both the groups will be provided another 10 sessions of
tDCS (2 sessions per day for the next 5 days), allowing a maximum gap of 72 hours between prior 10
sessions and the next 10 sessions. After completion of 20 sessions of tDCS, both groups will be subjected
to post intervention assessment (ACE-III, TMTApp, qEEG, fNIRS, CGI, WHODAS 2.0, NSI, tSEC).
The data obtained from the assessments will be analyzed. |