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CTRI Number  CTRI/2024/09/073378 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Behavioral 
Study Design  Randomized, Crossover Trial 
Public Title of Study   To study the effects of Transcutaneous Auricular Vagus Nerve Stimulation and cognition 
Scientific Title of Study   Transcutaneous Auricular Vagus Nerve Stimulation and Neurocognitive Processing: Investigating the effect of Transcutaneous Auricular Vagus Nerve Stimulation on P300 Event-related Potential in Auditory Oddball Paradigms. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gaurav Sharma 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Rajkot 
Address  All India Institute of Medical Sciences, Para Pipaliya, Rajkot
Department of Physiology, First Floor, Academic Block, AIIMS Rajkot.
Rajkot
GUJARAT
360006
India 
Phone  07417574751  
Fax    
Email  drgauravsharma.jnmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gaurav Sharma 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Rajkot 
Address  All India Institute of Medical Sciences, Para Pipaliya, Rajkot
Department of Physiology, First Floor, Academic Block, AIIMS Rajkot.

GUJARAT
360006
India 
Phone  07417574751  
Fax    
Email  drgauravsharma.jnmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gaurav Sharma 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Rajkot 
Address  All India Institute of Medical Sciences, Para Pipaliya, Rajkot
Department of Physiology, First Floor, Academic Block, AIIMS Rajkot.

GUJARAT
360006
India 
Phone  07417574751  
Fax    
Email  drgauravsharma.jnmc@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Para Pipaliya, Rajkot, Gujarat, India 360006 
 
Primary Sponsor  
Name  AIIMS Rajkot 
Address  All India Institute of Medical Sciences, Para Pipaliya, Rajkot, Gujarat, India 360006 
Type of Sponsor  Government medical college 
 
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 Gaurav Sharma  Neuro Cognitive Lab, Department of Physiology, First Floor, Academic Building, AIIMS Rajkot  All India Institute of Medical Sciences, Rajkot, Para pipaliya, rajkot, Gujarat 360006
Rajkot
GUJARAT 
7417574751

drgauravsharma.jnmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Rajkot, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal Healthy Individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  To study the effect of Sham taVNS on the P300 waveform.  Sham taVNS is applied and the effect is seen over cognitive parameters (P300 waveform) 
Intervention  to study the effect of taVNS and P300 waveform  Active taVNS is applied and the effect is seen over cognitive parameter (P300 waveform) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Apparently healthy individuals 
 
ExclusionCriteria 
Details  current cardiac or neurological diseases (including epilepsy or migraine).
family history of seizure disorders.
currently taking psychiatric medications.
smoking for a minimum of 5 hours preceding the testing session.
alcohol consumption in last 24 hours prior to testing.
caffeinated drinks and energy boosters for at least 2 hours before the testing session.
metal implants
pregnant participants 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of short-duration transcutaneous auricular vagal nerve stimulation (taVNS) have a significant impact on the latency and amplitude of P300 event-related potential (ERP) in auditory oddball paradigm when compared to sham and baseline conditions.  P300 at 15 minutes and 25 minutes during active or sham taVNS stimulation 
 
Secondary Outcome  
Outcome  TimePoints 
P 300 after the sham or active taVNS (During recovery phase).  after the taVNS & 10 minutes after the recovery, the P 300 waveform is recorded. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   16/09/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 vagus nerve (VN) is like a conductor in our body’s orchestra, helping to keep everything in harmony. It plays a vital role in maintaining balance and stability within our various bodily systems. For the past 30 years, doctors have used a method called invasive vagus nerve stimulation (iVNS) to treat conditions like drug-resistant epilepsy and treatment-resistant depression. However, iVNS involves surgery and has some tricky technical aspects, making it risky and complex.

To overcome these challenges, scientists have developed two non-invasive methods known as transcutaneous vagus nerve stimulation (tVNS). The first method targets the neck area but requires high-intensity stimulation and can be uncomfortable. The second approach, called transcutaneous auricular VN stimulation (taVNS), focuses on stimulating a part of the vagus nerve in the outer ear. This idea is supported by studies showing that certain areas of the ear are connected to the vagus nerve. By sending tiny electrical signals to these ear regions, we can potentially influence the vagus nerve’s activity within our brain and central structures, just like with iVNS but without the risks.

TaVNS has already received approval for treating conditions like epilepsy, depression, pain, and anxiety, and it’s being explored for many more uses. But beyond medical treatments, researchers are also curious about taVNS’s effects on our behavior, emotions, and thinking.

One essential aspect of our thinking is the P300 odd ball paradigm event-related potential (ERP). It’s like a signal in our brain that reflects higher-level thinking processes, attention, and memory. Interestingly, the P300 depends on another system in our brain called the locus coeruleus-norepinephrine (LC-NE) system.

This study plans to investigate how short bursts of taVNS affect our P300 signal compared to fake stimulation and normal conditions. What’s intriguing is that there have been only two previous studies on this topic, and they had different results.

By measuring the P300 signal at different times after taVNS, this research hopes to uncover the potential cognitive benefits of taVNS and how it interacts with the LC-NE network in our brains. In simpler terms, it’s like exploring a new, safe way to fine-tune our brain’s performance and improve our thinking abilities without surgery or major risks. This could open doors to exciting new possibilities for our brain health.

 
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