What side effects are associated with this type of intervention?

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Transcranial Magnetic Stimulation (TMS) are non-invasive treatments for depression. Common side effects of taVNS include mild discomfort at the stimulation site, such as tingling, redness, or itching. TMS may cause mild headaches, scalp discomfort at the stimulation site, and in rare cases, seizures. Both treatments are generally well-tolerated, with no serious adverse events reported in most studies.

What prior FDA approvals exist?

The FDA has approved several neuromodulation treatments for depression, including Transcranial Magnetic Stimulation (TMS). TMS uses magnetic fields to stimulate nerve cells in the brain and is approved for patients with treatment-resistant depression. Another related FDA-approved treatment is Vagus Nerve Stimulation (VNS), which involves surgically implanting a device that stimulates the vagus nerve to modulate brain activity. While taVNS, a non-invasive form of VNS, is still under investigation, these approvals highlight the FDA's recognition of neuromodulation as a viable treatment for depression.

What other types of research exist?

Promising novel alternatives to taVNS and TMS for depression treatment include: 1) Vagus Nerve Stimulation (VNS) - both invasive and non-invasive forms have shown potential in treating depression. 2) Deep Brain Stimulation (DBS) - involves implanting electrodes in specific brain areas to regulate abnormal impulses. 3) Cranial Electrotherapy Stimulation (CES) - uses a small device to send pulsed, low-intensity electrical currents to the brain. 4) Repetitive Transcranial Magnetic Stimulation (rTMS) - a variation of TMS that uses repeated magnetic pulses. 5) Single-pulse Transcranial Magnetic Stimulation (sTMS) - another variation of TMS that uses single magnetic pulses. These alternatives have shown varying degrees of efficacy and safety in clinical trials and may be considered for patients seeking novel treatments for depression.

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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 through study completion, an average of 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combined treatment for depression using electrical signals to a nerve in the ear and magnetic stimulation of the brain. It aims to see if this combination is more effective than either treatment alone. The study involves people with depression and uses methods that can help improve mood. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive procedure that stimulates electrical activity in the brain and has been found effective for treating depression.

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.

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.

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 week following conclusion of the trial

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week following conclusion of the trial

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week following conclusion of the trial for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Hamilton Depression Rating Scale

Change in Patient Health Questionnaire 9

Secondary study objectives

Number of adverse outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Transcranial Magnetic Stimulation

2017

Completed Phase 4

~730

Vagus Nerve Stimulation

2019

N/A

~50

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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.