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CTRI Number  CTRI/2024/10/075856 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [40Hz Binaural Beat Stimulation]  
Study Design  Randomized Factorial Trial 
Public Title of Study   A clinical trial to explore how 40Hz Binaural Beats may improve Attention and Brain Activity in patients with Depression 
Scientific Title of Study   The effect of 40Hz binaural beats on cognitive performance tests and qEEG parameters in adults with major depressive disorder: A randomized controlled trial 
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 Saran A K 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Physiology All India Institute of Medical Sciences Patna

Patna
BIHAR
801507
India 
Phone  9496323698  
Fax    
Email  saran11908@aiimspatna.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh Kumar 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Physiology All India Institute of Medical Sciences Patna

Patna
BIHAR
801507
India 
Phone  7759835573  
Fax    
Email  dryogeshk@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Dr Yogesh Kumar 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Physiology All India Institute of Medical Sciences Patna

Patna
BIHAR
801507
India 
Phone  7759835573  
Fax    
Email  dryogeshk@aiimspatna.org  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  Dr Saran A K 
Address  Senior Resident (Academic) Department of Physiology All India Institute of Medical Sciences Patna, Bihar 801507 India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogesh Kumar   Hospital Based  All India Institute of Medical Sciences, Patna
Patna
BIHAR 		 7759835573

dryogeshk@aiimspatna.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC -AIIMS Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G||Mental Health,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  40Hz Binaural Beats in addition to Treatment as Usual (TAU)  Binaural beats involve the presentation of two slightly different auditory frequencies to each ear, resulting in the perception of a rhythmic beat corresponding to the mathematical difference between the two frequencies. Among various frequencies, the stimulation at 40Hz has garnered particular attention due to its association with neural oscillations implicated in cognitive processes. Participants will be exposed to 40Hz binaural beats through headphones for 15 minutes for 5 days a week for over a 6-week period in addition to the standard treatment.  
Comparator Agent  Treatment as usual(TAU)  Participants will receive standard treatment regime for an equivalent period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 years or over who were diagnosed with 1st episode major depressive disorder according to DSM-V criteria.
2. Patients with acute phase major depressive disorder with mild to moderate severity according to Hamilton Depression Severity Scale.
 
 
ExclusionCriteria 
Details  1.Individuals with mental retardation or severe learning disabilities
2.Seizure disorders that require anticonvulsant therapy
3.A history of mania or psychosis
4.History of visual or hearing impairments
5.No other comorbid psychiatric disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cognitive Performance will improve through 40Hz binaural beat entrainment in MDD patients  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Quantifiable changes in qEEG parameters shedding light on the underlying neural mechanisms of the change, if any.  6 weeks 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   01/11/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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  

The effect of 40Hz binaural beats on cognitive performance tests and qEEG parameters in adults with major depressive disorder: a randomized controlled trial

Background: More than 300 million people worldwide suffer from depression, a common mental health illness. It is one of the main causes of disability and is characterized by cognitive deficits like indecision, trouble focusing, and memory issues. Even when other depression symptoms respond better to treatment, these cognitive deficiencies frequently linger. Empirical studies have demonstrated that depression-related cognitive deficits may impede complete recuperation, underscoring the necessity of cognitive-based therapies.

A developing non-pharmacological method that uses auditory stimulation is called binaural beats (BB). In each ear, two slightly different frequencies are played, and the brain interprets the difference in frequency as a beat. The 40Hz frequency, which is linked to gamma brainwaves, is especially significant since gamma waves are essential for cognitive processes like memory and attention. According to studies, 40Hz binaural beats synchronize brain activity, which may improve cognitive function.

Purpose: The purpose of this trial is to investigate whether 40Hz binaural beats can improve cognitive performance, specifically attention, and alter brainwave patterns (measured via qEEG) in adults with major depressive disorder (MDD). By using standardized cognitive tests and qEEG, the trial aims to understand the impact of this intervention on both cognitive performance and the underlying neural mechanisms in MDD patients. The trial will compare the outcomes of standard treatment alone versus standard treatment combined with 40Hz binaural beats, providing insights into its potential as a complementary therapy for cognitive impairment in depression.

 
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