Your session is about to expire
← Back to Search
Behavioural Intervention
taVNS + TMS for Depression
N/A
Recruiting
Led By Noah Vieira
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month following conclusion of the trial
Awards & highlights
Study Summary
This trial tests combining two treatments—nerve stimulation & magnetic stimulation—to treat depression better than either one alone. In-person at MUSC in Charleston, SC.
Who is the study for?
This trial is for adults aged 18-75 with severe depression, who haven't improved with talk therapy and have tried at least two antidepressants without success. It's also open to those already using cervical VNS. Participants must be able to consent, speak English, and not be pregnant or at high risk of suicide.Check my eligibility
What is being tested?
The study tests a combined depression treatment involving ear nerve stimulation (taVNS) and brain magnetic stimulation (TMS), separately or together. Over six sessions at the MUSC campus in Charleston, treatments are randomized across different days to assess which combination might best alleviate symptoms.See study design
What are the potential side effects?
Potential side effects may include discomfort from ear stimulation, headache or scalp sensations from TMS, temporary hearing changes due to taVNS, and mild dizziness or nausea. More serious risks could involve seizures from TMS but are considered rare.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month following conclusion of the trial
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month following conclusion of the trial
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Hamilton Depression Rating Scale
Change in Patient Health Questionnaire 9
Secondary outcome measures
Number of adverse outcomes
Trial Design
3Treatment groups
Experimental Treatment
Group I: Vagus Nerve Stimulation (VNS) onlyExperimental Treatment1 Intervention
Group II: Transcranial Magnetic Stimulation (TMS) onlyExperimental Treatment1 Intervention
Group III: Synchronized VNS and TMSExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vagus Nerve Stimulation
2019
N/A
~50
Transcranial Magnetic Stimulation
2017
Completed Phase 4
~730
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) works by stimulating the vagus nerve, which in turn modulates brain activity, potentially affecting mood regulation and depressive symptoms. Transcranial Magnetic Stimulation (TMS) uses magnetic fields to stimulate nerve cells in specific areas of the brain, such as the prefrontal cortex, which is often underactive in depression.
These treatments are significant for depression patients as they offer non-invasive options that can target brain regions and pathways involved in mood regulation, providing alternatives for those who do not respond to traditional pharmacotherapy.
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
940 Previous Clinical Trials
7,396,970 Total Patients Enrolled
40 Trials studying Depression
6,959 Patients Enrolled for Depression
Noah VieiraPrincipal InvestigatorMedical University of South Carolina
Mark George, MDStudy ChairMedical University of South Carolina
2 Previous Clinical Trials
1,019 Total Patients Enrolled
1 Trials studying Depression
795 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a legal guardian to make decisions for me due to cognitive issues.I am between 18 and 75 years old.I am receiving VNS for my neck or have tried two antidepressants without success.I can speak, read, and write in English.Talking therapy hasn't improved my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Synchronized VNS and TMS
- Group 2: Transcranial Magnetic Stimulation (TMS) only
- Group 3: Vagus Nerve Stimulation (VNS) only
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.
Share this study with friends
Copy Link
Messenger