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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 days
Awards & highlights
Study Summary
This trial will study if an ear stimulation called taVNS can help improve mental health symptoms of inpatients at the Institute of Psychiatry. Participants receive up to 9 daily treatments, lasting up to 30 mins each, with 30 min breaks in between. Questionnaires are taken before, during, and after.
Who is the study for?
This trial is for adults over 18 who speak English and are admitted to the Institute of Psychiatry with a primary diagnosis of depression. They must be able to consent and not have ear pain, recent trauma, metal implants in head/neck, history of brain surgery or seizures, severe substance use disorders, certain heart conditions, severe respiratory issues or COVID symptoms.Check my eligibility
What is being tested?
The study tests if transcutaneous auricular vagus nerve stimulation (taVNS) affects mental health symptoms in patients. Participants will receive up to nine taVNS treatments in one day or three daily treatments for three days. The effects are monitored through questionnaires about mood, anxiety, and sleep.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site on the ear. Since this is a non-invasive treatment focusing on ear stimulation, serious side effects are unlikely but could involve mild headaches or skin irritation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Side Effect and Adverse Event Report
Secondary outcome measures
General Anxiety Disorder-7 (GAD-7) Scale
Trial Design
2Treatment groups
Experimental Treatment
Group I: transcutaneous auricular neurostimulation (low dose)Experimental Treatment1 Intervention
All taVNS procedures will be conducted using the Spark Biomedical device. Electrodes will be placed on the left auricle and we will use stimulation parameters similar to ongoing taVNS work (25Hz, 500us pulse width) and a duty cycle of 1 minute on, 30 s off, repeated for 30 minutes. The low dose taVNS group will receive up to 3 treatments per day over the course of 3 days (for a total of up to 9 treatments).
Group II: transcutaneous auricular neurostimulation (high dose)Experimental Treatment1 Intervention
All taVNS procedures will be conducted using the Spark Biomedical device. Electrodes will be placed on the left auricle and we will use stimulation parameters similar to ongoing taVNS work (25Hz, 500us pulse width) and a duty cycle of 1 minute on, 30 s off, repeated for 30 minutes. The high dose taVNS group will receive up to 9 treatments in a single day.
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,626 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to participate in the consent process due to my condition.My primary diagnosis is depression.I have had a serious head injury or concussion in the past.I am currently experiencing a severe flare-up of my lung condition or symptoms from COVID.I have a history of psychosis or mania, or I am currently experiencing these conditions.I have had recent pain in my face or ear, or an injury to my ear.I have metal implants in my head, heart, or neck.I have had a heart attack or an irregular heartbeat.I have a history of seizures or take medications that can lower my seizure threshold.I can make my own medical decisions and sign consent forms.I often have severe headaches.I have had brain surgery in the past.I am 18 years old or older.I have stomach issues due to my diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: transcutaneous auricular neurostimulation (low dose)
- Group 2: transcutaneous auricular neurostimulation (high dose)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression and Anxiety Patient Testimony for trial: Trial Name: NCT05791383 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total headcount of participants engaging in this experiment?
"Affirmative. Clinicaltrials.gov contains evidence that this medical study, which was first published on December 1st 2022, is actively recruiting participants. The goal is to enroll 10 individuals from a single clinical site."
Answered by AI
Is this clinical experiment currently enrolling participants?
"Affirmative. Information found on clinicaltrials.gov states that this research is in the process of recruiting patients, which began after its first posting on December 1st 2022 and was last updated March 28th 2023. The trial requires 10 individuals from a single location to participate."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
Georgia
What site did they apply to?
Medical University of South Carolina Institute of Psychiatry
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I've been battling with depression, anxiety and ADHD for nearly 23 years. I thought I would grow out of it but so far, not much has changes. Mental disease runs pretty rampant in my family period from schizophrenia to Bipolar depression. I often self medicate with my ADHD medication because I think that it helps my depression and anxiety by covering up the issues. It's greatly affected my ability to socialize. I've become more isolated as I get older. I know there's a better way and I want to find it while I'm still relatively young.
PatientReceived no prior treatments
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