Clinical trial NCT05801809: Understanding the Effects of Transauricular Vagus Nerve Stimulationon on Neural Networks and Autonomic Nervous System
Official title: Understanding the Effects of Non-invasive Transauricular Vagus Nerve Stimulation (taVNS) on Neural Networks and Autonomic Nervous System: a Randomized Double-blind Sham-control Mechanistic Trial in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Keywords: vagal nerve stimulation
healthy subjects
biomarkers
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This trial aims to perform an exploratory, mechanistic, randomized double-blind sham-control trial in healthy participants to assess the physiologic effects of a single 60 minutes session of bilateral taVNS, on neural networks and autonomic function.

Detailed description: Several studies have shown promising results of taVNS to treat various disorders such as depression, anxiety, Alzheimer's disease, headache, obesity, and diabetes. However, no mechanistic studies have investigated the taVNS neural network and autonomic nervous system effects of this technique. Therefore, we aim to assess how taVNS can affect EEG metrics and HRV and assess its safety. Also, we aim to evaluate predictors that can influence the response to taVNS, so understanding the variables associated with response to taVNS can help the design of future clinical trials to maximize the effects of this intervention.

Eligibility criteria: Inclusion Criteria:

1. Able to provide informed consent to participate in the study.
2. Subject is older than 18 years.
3. Subjects should be naive to the stimulation (taVNS)

Exclusion Criteria:

1. Pregnancy.
2. Subjects who have had a neuropsychiatric or a cardiac disorder diagnosis and have received treatment and chronic medication in the past six months, or who have functional deficits as a result.
3. History of alcohol or drug abuse within the past 6 months as self-reported.
4. Presence of the following contraindication to transauricular vagus nerve stimulation

   1. Ferromagnetic metal in the head and in the cranium (e.g., plates or pins, bullets, shrapnel)
   2. Implanted cranial electronic medical devices (e.g., cochlear implants)
   3. Implanted cardiac devices (e.g., pacemaker)
5. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure, or chronic obstructive pulmonary disease).
6. Uncontrolled epilepsy, as defined by previous clinical seizures in the past 3 months in patients with treatment for epilepsy.
7. Suffering from severe depression (as defined by a score of \>30 in the Beck Depression Inventory).

Primary outcomes:
measure: Resting-state electroencephalogram (EEG)
timeFrame: Change from baseline resting-state EEG at 60 minutes.
measure: Electroencephalogram (EEG) event-related potentials
timeFrame: Change from baseline EEG event-related potentials at 60 minutes.
measure: Quantitative sensory testing (QST)
timeFrame: Change from baseline QST at 60 minutes.
Secondary outcomes:
measure: Heart rate variability (HRV)
timeFrame: Change from baseline HRV at 60 minutes.
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Spaulding Hospital Cambridge
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital/Harvard Medical School
name: Felipe Fregni, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: