| CTRI Number |
CTRI/2026/01/100806 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [FM theta EEG Neurofeedback ] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of brainwave assisted Focused attention training on mind wandering in healthy people |
|
Scientific Title of Study
|
Mapping of EEG-microstate-dynamics and the effect of frontal-midline-theta training on phenomenology of spontaneous mentation among healthy adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAVINDRA PN |
| Designation |
Additonal Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Center for Consciousness studies, Department of Neurophysiology,
Hosur Road, National Institute of Mental Health and Neurosciences (NIMHANS). Bangalore KARNATAKA 560029 India |
| Phone |
09448934488 |
| Fax |
|
| Email |
ravindrapinna@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Amritharekha P |
| Designation |
Ph.D. student |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Center for Consciousness studies, Department of Neurophysiology,
Hosur Road, National Institute of Mental Health and Neurosciences (NIMHANS).
Bangalore KARNATAKA 560029 India |
| Phone |
9740247474 |
| Fax |
|
| Email |
amritharekhanayak@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
RAVINDRA PN |
| Designation |
Additonal Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Center for Consciousness studies, Department of Neurophysiology,
Hosur Road, National Institute of Mental Health and Neurosciences (NIMHANS). Bangalore KARNATAKA 560029 India |
| Phone |
09448934488 |
| Fax |
|
| Email |
ravindrapinna@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences (NIMHANS) |
|
|
Primary Sponsor
|
| Name |
Dr Ravindra PN |
| Address |
Additional Professor,
Centre for Consciousness Studies Department of Neurophysiology NIMHANS.
|
| 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 RAVINDRA PN |
National Institute of Mental Health and Neurosciences |
Center for Consciousenss Studies, Human Cognition Laboratory
Department of Neurophysiology, NIMHANS,
Hosur Rd, near Bangalore Milk Dairy, Hombegowda Nagar, Bengaluru, Karnataka 560029
Bangalore KARNATAKA |
09448934488
RAVINDRAPINNA@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Institute Ethics committee Basic and Neuroscience division |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EEG Frontal-midline theta Neuro-feedback |
EEG based Neuro-feedback specifically to enhance Frontal-midline theta (FM-theta) activity will be the intervention. Modalities to enhance FM theta will be different breathing protocols; breathing induced EEG (FM-theta) changes will be feedback given in the gamified way. The study design is cross-over design where each subjects undergo Neuro-feedback training protocol for 8 days spanning 2 weeks and it is compared against their sham training session. |
| Comparator Agent |
Sham EEG based Frontal-midline theta (FM-theta) Neuro-feedback |
In sham training session the same breathing protocols will be followed except the feedback received will not match their EEG (FM-theta) changes. The neuro-feedback and sham session will be at a minimum of 4 weeks apart. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers
Age 18-35 years
Both genders
PHQ 9 scored between 0-9 |
|
| ExclusionCriteria |
| Details |
Subjects with neurological neurodegenerative neuropsychiatric conditions and on medications
PGQ 9 scored more than 10
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EEG microstates and Mind wandering |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
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)
|
31/01/2026 |
| 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 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 - NO
|
|
Brief Summary
|
The EEG based neurofeedback is a noninvasive non pharmacological approach to modulate cognitive functions underlying attention and emotional regulation. A Study reported giving Frontal midline EEG activity in theta range as feedback using breathing protocols enhances executive functioning of the participants . They employed eight days of protocol in where training is done within two consecutive weeks. Inspired by this we are employing the same protocol for understanding mind wandering phenomenology. Internal focus such as Meditation increases FM theta oscillations . And Mind wandering is a common confounder seen during sustained attention periods. Thus training individuals in focused attention methods might impact mind-wandering episodes. In present study the participants will undergo 2week FM theta training focused on understanding the effect of focused attention training on the phenomenology of mind wandering (spontaneous mentation). Assessment of pre and post Mind wandering will be done via sustained attention paradigm, where participants are probed with questions related to their attention status and also will encourage them to report when every they self-catch their thoughts during the sustain attention task. The whole protocol will be of 2 weeks span and with minimum of 4 weeks time for wash out subject will undergo sham training protocols. The study design is cross over where half of the participants will receive FM theta training protocol and other half sham protocol as their first session subsequently after the washout gap they will receive the other half. Study hypothesis Frontal-midline theta focused attention training will influence the contents of spontaneous mentation (mind wandering) and its EEG microstate dynamics Aim To evaluate the effect of frontal-midline-theta focused attention training on phenomenology of spontaneous mentation and its EEG microstate dynamics among healthy adults
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