Comparison of Effectiveness In-ear & Behind-ear Vagus Nerve Stimulation

Status Completed

Clinical Trial Summary

The use of vagus nerve stimulation (VSS), one of the examples of neuromodulation therapies, continues to increase in the medical field. Basically, invasive (iVSS) and transcutaneous VSS (tVSS) can be performed. tVSS is more preferred because of its advantages such as easy application, not requiring surgical procedure and having fewer side effects. VSS has long been an approved treatment modality in the treatment of epilepsy and refractory depression. tVSS can be administered from the auricular-auricular or posterior ear region. The vagus nerve (VS) belongs to the parasympathetic branch of the autonomic nervous system and has an effect on vital functions. There are also studies in the literature showing that VS stimulation reduces inflammation. In addition to this effect, the vagus nerve may also show analgesic activity through pain-related pathways. Due to its anti-inflammatory and analgesic effects, VSS has become a new treatment method in diseases in which various inflammatory processes are shown in the etiology such as inflammatory bowel diseases, musculoskeletal system diseases and central nervous system diseases.

Clinical Trial Description

There are no generally accepted values for taVNS (transcutaneous auricular vagus nerve stimulation) application parameters (amplitude, frequency, intensity, duration, side); therefore, there are heterogeneous applications in studies. In a meta-analysis on the safety profile of taVSS, local skin irritation (18. 2%), headache (3.6%), nasopharyngitis (1.7%), dizziness (1.4%) and nausea (1.1%) were reported and taVSS treatment was reported as an effective and safe treatment with these side effects, most of which were transient and did not require additional intervention. During taVNS, autonomic activities increase in favour of the parasympathetic system and this results in an increase in heart rate variability (HRV). Although an increase in HRV has been demonstrated by different studies, the factors that can predict the change in HRV are not clear. In a study by Geng et al. using taVSS, it was observed that HRV indicators representing vagal nerve activity increased significantly when stimulation was performed in the morning, but evening stimulation did not yield similar results. In addition, they found that improvements in measures of autonomic balance were more pronounced in the presence of lower vagal activity; they also found that by increasing the duration of stimulation, the effect of taVNS on HRV was not regulated by duration. In other words, HRV changes had the best effect only at the beginning of stimulation. ;

Study Design

Related Conditions & MeSH terms

Vagus Nerve Stimulation

Clinical Trial Details

NCT number	NCT06312293
Study type	Interventional
Source	Bahçesehir University
Contact
Status	Completed
Phase	N/A
Start date	September 15, 2023
Completion date	December 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05343039` - Technology Enhanced Adolescent Mental Health (TEAM)	N/A
Recruiting	`NCT05992259` - Auricular Vagus Stimulation and STEMI	N/A
Completed	`NCT04643808` - taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds	Early Phase 1
Not yet recruiting	`NCT05417711` - Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus	N/A
Not yet recruiting	`NCT06121947` - Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia	N/A
Completed	`NCT04150627` - Effect of Breathing Maneuvers on Peripheral Glucose Metabolism	N/A
Not yet recruiting	`NCT06381089` - Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients	N/A
Terminated	`NCT04256837` - Effect of Transcutaneous Electrical Auricular Stimulation of the Vagus Nerve in Kidney Transplant Recipients	N/A
Completed	`NCT05218109` - Stress and Sleep Study	N/A
Recruiting	`NCT05680337` - Auricular Vagus Stimulation and Heart Rate Variability	N/A
Not yet recruiting	`NCT05088135` - The Effect of Auricular Vagus Nerve Stimulation on EEG and EMG Measurement in Healthy Persons	N/A
Not yet recruiting	`NCT05866471` - Pairing Psilocybin With Transauricular Vagus Nerve Stimulation	Phase 1
Active, not recruiting	`NCT04632069` - NAC +taVNS in IDM Who Are Poor Oral Feeders	Early Phase 1
Active, not recruiting	`NCT05230628` - Auricular Vagus Stimulation in Obesity	N/A
Completed	`NCT06086236` - Vagus Nerve Stimulation Effects on Autonomic Nervous System Activity	N/A
Completed	`NCT04341649` - Multi-device Testing for Autonomic Nervous System Stimulation	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of Effectiveness In-ear and Behind-ear Vagus Nerve Stimulation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms