| 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
|
|
|
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
|
|
|
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. |