What side effects are associated with this type of intervention?

Common treatments for depression, such as neuromodulation techniques like transcutaneous vagus nerve stimulation (tVNS) and transcranial magnetic stimulation (TMS), are generally well-tolerated but can cause mild side effects like tingling, redness, itching, and muscle spasms. Pharmacological treatments, particularly SSRIs and SNRIs, can cause side effects including nausea, weight gain, sexual dysfunction, fatigue, and insomnia. Both treatment types aim to modulate brain activity to alleviate depressive symptoms.

What prior FDA approvals exist?

The FDA has approved several neuromodulation techniques for the treatment of depression. Vagus nerve stimulation (VNS) has been approved for treatment-resistant depression, showing efficacy in reducing depressive symptoms over long-term use. Transcranial magnetic stimulation (TMS) is another FDA-approved treatment for major depressive disorder, particularly for patients who have not responded to antidepressant medications. These treatments aim to modulate neural activity and have shown promise in alleviating symptoms of depression. Additionally, various pharmacological treatments, such as selective serotonin reuptake inhibitors (SSRIs) and atypical antipsychotics, have been approved for managing depression.

What other types of research exist?

Promising, novel alternatives to expiratory-gated transcutaneous vagus nerve stimulation (tVNS) for treating depression include: 1) Transcranial Magnetic Stimulation (TMS), which has demonstrated efficacy in reducing depressive symptoms and is non-invasive. 2) Deep Brain Stimulation (DBS), which is more invasive but has shown potential in treatment-resistant cases. 3) Noninvasive Vagus Nerve Stimulation (nVNS), which has shown benefits in acute treatment settings. These alternatives offer varying degrees of invasiveness and efficacy, providing options for personalized treatment plans.

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Behavioural Intervention

tVNS for Depression (tVNS_MDD_Sex Trial)

N/A

Recruiting

Led By Ronald G Garcia, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current or past diagnosis of recurrent Major Depressive Disorder

Be older than 18 years old

Must not have

Traumatic brain injury with cognitive sequelae

History of neuroleptic use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours

Summary

This trial tests a non-invasive treatment that uses mild electrical stimulation on the skin to help adults with recurrent major depressive disorder. The treatment aims to improve mood and reduce stress by sending signals to a specific nerve. Researchers will study how this affects brain activity and physiological responses, considering differences between men and women.

Who is the study for?

This trial is for adults over 50 with a current or past diagnosis of recurrent Major Depressive Disorder. It's not suitable for those with traumatic brain injury, MRI/tVNS contraindications like claustrophobia or metallic implants, history of psychosis, recent severe substance use disorder, significant heart/cerebrovascular disease, CNS diseases (like MS or epilepsy), or pregnant women due to potential risks.

What is being tested?

The study tests if transcutaneous vagus nerve stimulation (tVNS) can affect stress response in depression differently based on sex. Participants will be randomly assigned to receive either active tVNS or a sham treatment during an fMRI scan while mood and physiological responses are monitored.

What are the potential side effects?

Potential side effects from tVNS may include discomfort at the stimulation site, headache, voice changes due to laryngeal muscle stimulation, shortness of breath if respiratory muscles are affected and possible skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Major Depressive Disorder more than once.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have thinking or memory problems due to a head injury.

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I have taken medication for mental health issues.

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I have not had thoughts of suicide or attempted suicide in the past year.

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I do not have MS, epilepsy, or similar brain diseases.

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I have a serious heart or blood vessel condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Brain activity during functional magnetic resonance imaging (fMRI)

Cardiac autonomic function during functional magnetic resonance imaging (fMRI)

Secondary study objectives

Change in depressive symptoms assessed by the Beck Depression Inventory

Change in serum cortisol levels

Change in serum levels of pro-inflammatory cytokines

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tVNSExperimental Treatment1 Intervention

Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle

Group II: Sham tVNSPlacebo Group1 Intervention

Sham transcutaneous vagus nerve stimulation on the left auricle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

active tVNS

2019

N/A

~20

0 / 6Eligibility criteria met

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

Common treatments for depression include pharmacotherapy, psychotherapy, and neuromodulation techniques. Pharmacotherapy typically involves antidepressants that modulate neurotransmitters like serotonin, norepinephrine, and dopamine to improve mood and emotional regulation. Psychotherapy, such as cognitive-behavioral therapy (CBT), helps patients develop coping strategies and alter negative thought patterns. Neuromodulation techniques, such as transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS), target specific brain regions to modulate neural activity and improve mood. Expiratory-gated transcutaneous vagus nerve stimulation (tVNS) specifically aims to modulate the stress response circuitry and attenuate physiological deficits in major depressive disorder (MDD). Understanding these mechanisms is crucial for tailoring treatments to individual patients, potentially leading to more effective and personalized care.

Pathophysiology of depression: the concept of synaptic plasticity.