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Neurostimulation

Ear Stimulation for Brain Activity

N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65
Have the capacity and ability to provide one's own consent and sign the informed consent document
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during tan
Awards & highlights

Study Summary

This trial will use a novel electrode device to stimulate 4 different parts of the ear to see if it affects brain activity. Results will be compared to see which has greatest effect.

Who is the study for?
This trial is for individuals aged 18-65 who can consent to participate. It's not suitable for those with frequent/severe headaches, contraindications for MRI, untreated medical/neurological/psychiatric conditions, psychosis or mania history, metal implants in head/heart/neck, brain surgery or heart issues history, seizure risk factors like family history or certain medications use, significant head injury history, substance abuse problems or if pregnant.Check my eligibility
What is being tested?
The study tests the effects of transcutaneous auricular neurostimulation (tAN) on two cranial nerves during an fMRI scan. Participants will be randomly assigned to receive tAN targeting different nerve combinations (vagus nerve alone, trigeminal branch alone, both together) versus a sham (fake stimulation), to see which has greater neurological impact.See study design
What are the potential side effects?
While specific side effects are not detailed here as it's a non-invasive stimulation technique and generally considered safe when properly administered under clinical supervision; potential discomfort at the site of electrode placement may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I can make my own medical decisions and sign consent forms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during tan
This trial's timeline: 3 weeks for screening, Varies for treatment, and during tan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BOLD signal changes during stimulation relative to no stimulation

Trial Design

5Treatment groups
Active Control
Placebo Group
Group I: Auricular Neurostimulation (Active 3)Active Control1 Intervention
•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)
Group II: Auricular Neurostimulation (Active 1)Active Control1 Intervention
•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)
Group III: Auricular Neurostimulation (Active 2)Active Control1 Intervention
•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)
Group IV: Auricular Neurostimulation (Sham 2)Placebo Group1 Intervention
•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)
Group V: Auricular Neurostimulation (Sham 1)Placebo Group1 Intervention
•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)

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
930 Previous Clinical Trials
7,393,715 Total Patients Enrolled

Media Library

tAN (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05487664 — N/A
Ear Stimulation Research Study Groups: Auricular Neurostimulation (Sham 2), Auricular Neurostimulation (Sham 1), Auricular Neurostimulation (Active 3), Auricular Neurostimulation (Active 1), Auricular Neurostimulation (Active 2)
Ear Stimulation Clinical Trial 2023: tAN Highlights & Side Effects. Trial Name: NCT05487664 — N/A
tAN (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05487664 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial cater to individuals aged 50 and above?

"The age requirements for this trial are clear; all participants must be 18 years of age or older and no one may exceed 65."

Answered by AI

Who is eligible for involvement in this clinical research?

"This research is seeking 96 participants aged between 18 and 65 for ear stimulation. Prospective individuals must demonstrate their ability to offer informed consent, as well as fulfil the age requirements."

Answered by AI

How many participants are currently being recruited into this experiment?

"Affirmative. According to clinicaltrials.gov, this trial is actively recruiting subjects who meet the criteria for participation. The first posting was on March 17th 2023 and has since been updated as recently as March 28th 2023 - with a target of 96 potential recruits from 1 specific medical centre."

Answered by AI

Are researchers still enrolling participants in this research endeavor?

"Affirmative. Clinicaltrials.gov data reveals that this medical trial is presently recruiting volunteers, with the initial posting occurring on March 17th 2023 and changes being made to it as recently as March 28th of the same year. The investigation seeks to involve 96 research subjects from a single centre."

Answered by AI
~64 spots leftby Jan 2027