RM1 Project 2 - tAN fMRI

Conditions

• Auricular Stimulation

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Transcutaneous Auricular Neruostimulation (tAN) — DEVICE
  The intervention we are studying is called transcutaneous auricular neurostimulation (tAN). tAN is simply electrical nerve stimulation administered at the ear which targets both the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN, a branch of the trigeminal nerve).

Study Details

In this one-visit, randomized, double-blind, sham-controlled trial, we plan to use a novel concurrent transcutaneous auricular neurostimulation (tAN) paradigm during functional magnetic resonance imaging (fMRI) paradigm in 96 individuals to determine whether tAN administered to two cranial nerves simultaneously produces greater neurophysiologic effects than stimulating solely to the auricular branch of the vagus nerve (ABVN) or the auriculotemporal nerve (ATN; branch of trigeminal nerve) alone. Within the MRI scanner, each participant will be connected to a series of electrodes that stimulate 4 targets (ABVN only, ATN only, ABVN plus ATN, and Sham).

Key Dates

Start date

Mar 17, 2023

Status verified

Dec 2025

Primary completion

Jan 1, 2027

Completion

Oct 1, 2027

Study Design

Enrollment

96 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Active Comparator: Auricular Neurostimulation (Active 1)
  •Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target -ABVN Only stimulation (15Hz stimulation of cymba conchae)
• Active Comparator: Auricular Neurostimulation (Active 2)
  •Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target -ATNS Only stimulation (100Hz stimulation of the tragus)
• Active Comparator: Auricular Neurostimulation (Active 3)
  •Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target -Combo stimulation (stimulation of both the 15Hz cymba conchae and 100HZ tragus)
• Sham Comparator: Auricular Neurostimulation (Sham 1)
  •Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target -Sham (15Hz stimulation of the earlobe)
• Sham Comparator: Auricular Neurostimulation (Sham 2)
  •Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target -Sham (100Hz stimulation of the earlobe)

Primary Outcome Measure

BOLD signal changes during stimulation relative to no stimulation [ Time Frame: During tAN ]

Central Contacts

• Bashar Badran, PhD
  843-792-6076
  [email protected]

Locations (1)

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