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Clinical Trials/CTRI/2024/10/075856
CTRI/2024/10/075856RecruitingNot Applicable

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

Dr Saran A K1 site in 1 country52 target enrollmentStarted: November 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
52
Locations
1
Primary Endpoint
Cognitive Performance will improve through 40Hz binaural beat entrainment in MDD patients

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients aged 18 years or over who were diagnosed with 1st episode major depressive disorder according to DSM-V criteria.
  • Patients with acute phase major depressive disorder with mild to moderate severity according to Hamilton Depression Severity Scale.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Cognitive Performance will improve through 40Hz binaural beat entrainment in MDD patients

Time Frame: 6 weeks

Secondary Outcomes

  • Quantifiable changes in qEEG parameters shedding light on the underlying neural mechanisms of the change, if any.(6 weeks)

Investigators

Sponsor
Dr Saran A K
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Saran A K

All India Institute of Medical Sciences Patna

Study Sites (1)

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