| CTRI Number |
CTRI/2024/06/069035 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Neurofeedback] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the improvement on behavioural outcome after neurofeedback training on ADHD children. |
|
Scientific Title of Study
|
Effectiveness of slow cortical potential neurofeedback in comparison to
stimulant medication methylphenidate on behavioral outcomes in children with
attention deficit hyperactivity disorder. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritambhara Mandal |
| Designation |
PGT, MD Psychiatry |
| Affiliation |
Institute of Psychiatry |
| Address |
Institute of Psychiatry -COE, site 2, 7 DL Khan road, Kolkata, West Bengal
Department of Psychiatry
Kolkata
WEST BENGAL
700025
India |
| Phone |
9831892266 |
| Fax |
|
| Email |
mandalritambhara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Supartha Barua |
| Designation |
Assistant Professor,IOP-COE,Kolkata |
| Affiliation |
Institute of Psychiatry |
| Address |
Institute of Psychiatry- A Centre of Excellence, site 2, 7 DL Khan road, Kolkata, West Bengal
Department of Psychiatry
Kolkata
WEST BENGAL
700025
India |
| Phone |
9830624039 |
| Fax |
|
| Email |
supartha.supartha.barua@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ritambhara Mandal |
| Designation |
PGT, MD Psychiatry |
| Affiliation |
Institute of Psychiatry |
| Address |
Institute of Psychiatry -COE, site 2, 7 DL Khan road, Kolkata, West Bengal
Department of Psychiatry
Kolkata
WEST BENGAL
700025
India |
| Phone |
9831892266 |
| Fax |
|
| Email |
mandalritambhara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Psychiatry-COE Department of Psychiatry, 7 DL Khan road, Kolkata 700025 |
|
|
Primary Sponsor
|
| Name |
Ritambhara Mandal |
| Address |
Institute of Psychiatry-COE Department of Psychiatry,site 2, 7 DL Khan road ,Kolkata 700025 |
| 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 Ritambhara Mandal |
Institute of Psychiatry-A Centre of Excellence |
7 DL Khan road, Kolkata 700025
Department of Psychiatry, OPD, room no 1.
Kolkata
WEST BENGAL |
9831892266
mandalritambhara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Methylphenidate |
Comparator group will receive only stimulant medication, Methylphenidate, will be followed up after 3 months. |
| Intervention |
Neurofeedback |
Intervention group will receive
24 sessions of slow cortical potential neurofeedback, along with medication, twice weekly, each session will last for 16 minute, 80 trials, will be followed up after 3 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Aged 6 to 12 years
2) Fulfilling the diagnostic criteria according to DSM 5
3)Fulfilling the criteria of CONNERS 3AI, ADHD Indicator scale as screening tool
4) Children with no contraindication for methylphenidate
5) parents are willing to give informed consent on behalf of their children
and compliant to therapy |
|
| ExclusionCriteria |
| Details |
1) Children with Intellectual deficit disorder and Autism spectrum disorder
2) Any neurological like seizure disorder or physical illness
3) Any other significant psychiatric illness like mood disorder ,psychosis ,obsessive compulsive
disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neurofeedback is effective on behavioural outcomes of ADHD in comparison to stimulant medication ,according to conners 3 parent short scale |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neurofeedback improves inattention, hyperactivity, impulsivity, executive function, defiance or aggression and peer relation in children with ADHD |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/06/2024 |
| 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
|
This study is a randomized , parallel group trial where 60 childrens diagnosed with ADHD will be divided into two groups, one group will receive neurofeedback along with stimulant medication and another group will receive only stimulant medication that is methylphenidate . There will be 24 sessions and each session will be of 16 minutes .follow up will be done after 3 months as per conners 3 parent short scale . Primary outcome measures how much effective the neurofeedback is in comparison to stimulant medication. |