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临床试验/CTRI/2024/09/073378
CTRI/2024/09/073378尚未招募不适用

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.

AIIMS Rajkot1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Apparently healthy individuals.

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: P300 at 15 minutes and 25 minutes during active or sham taVNS stimulation

次要结局

  • 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.)

研究者

发起方
AIIMS Rajkot
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Gaurav Sharma

All India Institute of Medical Sciences, Rajkot

研究点 (1)

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