| CTRI Number |
CTRI/2026/02/104808 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [NON PHARMACOLOGICAL (BINAURAL BEATS) ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EEG Waves in Depression with Binaural beats and motor tasks, correlation with sex hormones. |
|
Scientific Title of Study
|
Electrophysiological measures of sensory-motor tasks in patients with depression and possible correlation with sex hormones |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NAVEEN KUMAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS JODHPUR |
| Address |
18/752 Chopasani housing board Jodhpur,342008 Rajasthan,India.
EEG Lab,C-032 Physiology Department ALL INDIA INSTITUTE OF MEDICAL SCIENCE Jodhpur, Basni Industrial Area Phase 2, Jodhpur - 342005,Rajasthan India
Jodhpur
RAJASTHAN
342008
India |
| Phone |
09587112813 |
| Fax |
|
| Email |
nk528163@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR POOJA OJHA |
| Designation |
Additional Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
C-058 Physiology Department All India Institute of Medical Sciences, Jodhpur
Basni Industrial Area Phase 2, Jodhpur - 342005
C-058 Physiology Department, All India Institute of Medical Sciences, Jodhpur
Basni Industrial Area Phase 2, Jodhpur - 342005
Jodhpur
RAJASTHAN
342008
India |
| Phone |
9919816596 |
| Fax |
|
| Email |
ojhap@aiimsjodhpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR POOJA OJHA |
| Designation |
Additional Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
C-058 Physiology Department All India Institute of Medical Sciences, Jodhpur
Basni Industrial Area Phase 2, Jodhpur - 342005
C-058 Physiology Department All India Institute of Medical Sciences, Jodhpur
Basni Industrial Area Phase 2, Jodhpur - 342005
Jodhpur
RAJASTHAN
342008
India |
| Phone |
9919816596 |
| Fax |
|
| Email |
ojhap@aiimsjodhpur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science (AIIMS) Jodhpur,Basni Industrial Area Phase 2, Jodhpur-342005 Rajasthan India. |
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
All India Institute of Medical Sciences (AIIMS),Jodhpur
Basni Industrial Area Phase 2, Jodhpur-342005,Rajasthan,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 NAVEEN KUMAR |
AIIMS JODHPUR |
C-032 EEG Laboratory Physiology Department, All India Institute of Medical Science (AIIMS) Jodhpur 342005, Rajasthan India.
Jodhpur
RAJASTHAN |
09587112813
nk528163@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ehics Committee All India Institute of Medical science, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
40 HEALTHY CONTROLS & 64 DEPRESSION SUBJECTS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BINAURAL BEATS |
Binaural beats are auditory illusions where a subject listens to two different frequencies in each ear. Binaural beats at specific frequencies serve distinct purposes. When a subject is exposed to a Theta pattern of 4-7 Hz for 20 minutes it promotes relaxation and enhances mood and creativity.
When Binaural beats 400Hz in Left ear and 407 Hz in right ear, Theta range for 20 minutes only once given to subjects. |
| Comparator Agent |
healthy controls will recieve binaural beats andd some of them will not recieve BB |
Healthy controls will be divided in two groups one will recieve Binaural beats for 20 minutes and one will not recieve and will recieve Pink noise for 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1: Patients of both sexes, diagnosed with depression according to DSM 5 criteria, between 18 years to 45 years, and who provide consent.
2: Minimum education: 5th Standard
3: Age and sex-matched healthy controls
4: Recruit female patients in follicular phase
|
|
| ExclusionCriteria |
| Details |
1: History of other neuropsychiatric disorders or chronic medical conditions.
2: History of alcohol and tobacco or substance abuse.
3: History of any motor disorder
4: Pregnant females and those taking contraception.
5: Hearing defect: A tuning fork test will be done to check hearing
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare EEGs during rest and sensory-motor testing in patients with depression and healthy controls.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the possible association between estrogen, progesterone levels & EEG parameters in female patients with depression.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
09/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/03/2026 |
| 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
|
STUDY PROCEDURE AND DATA COLLECTION The study will be conducted after obtaining written informed consent from patients and controls, which includes 64 patients with depression (both males and females) and 40 healthy male and female subjects aged 18 to 45 years. Subjects who meet the inclusion criteria will be recruited. The study procedure will be explained to the participants. Using a randomization method, 64 depressed patients will be divided into two groups: 32 patients will receive Binaural Beats, while the other 32 will not receive Binaural Beats and will only receive pink noise. Of the 40 healthy controls, 20 will be given Binaural Beats and 20 will receive pink noise. Saliva samples for estrogen and progesterone will be collected from female patients, who will be asked to revisit the outpatient department according to the next phase of their menstrual cycle. The saliva samples will be frozen and subsequently analyzed for estrogen and progesterone using ELISA kits. The experiment consists of three sessions. In the first part, baseline EEG will be recorded for 10 minutes using RMS Superspec 32 equipment with 32 channels simultaneously with EEG. The spectral power in different EEG frequency bands of depression patients will be compared with healthy subjects. After the baseline recording, a saliva sample will be taken. Following that, a 5-minute resting period will be given to the participant. In the second part, the participant will receive auditory sensory stimuli in the form of binaural beats in the theta band at 5-7 Hz. Binaural beats will be generated by publicly available software or applications, using a 400 Hz standard tone in the left ear and a 407 Hz tone in the right ear, played through earphones for 20 minutes. Attention and psychomotor tasks (Trail Making Task) will be assessed before and after the auditory sensory stimuli. Part A involves connecting a series of 25 circles with numbers 1 to 25 in ascending order. Part B involves connecting 25 circles with alternating numbers and letters (1-A, 2-B) in sequence. This test will assess psychomotor speed and attention. It will be followed by a five-minute rest. In the third part, motor assessment will be conducted using a hand grip test and finger tapping for fine motor activity over 5 minutes, while EEG is recorded simultaneously. In the hand grip test, the maximum power of the subject is assessed with a dynamometer, and 33% of that power will be set for 1 minute while simultaneous EEG recording is performed for 5 minutes to assess muscular function. The finger tapping test requires pressing keyboard buttons with the right and left index fingers without moving the entire hand for 10 seconds, while the number of taps is counted by software to determine fine motor activity. |