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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 belowSelect...
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:Select...
I have thinking or memory problems due to a head injury.
Select...
I have taken medication for mental health issues.
Select...
I have not had thoughts of suicide or attempted suicide in the past year.
Select...
I do not have MS, epilepsy, or similar brain diseases.
Select...
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
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
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.
Pathophysiology of depression: the concept of synaptic plasticity.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,020 Previous Clinical Trials
13,316,435 Total Patients Enrolled
193 Trials studying Depression
34,062 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,927 Previous Clinical Trials
2,744,687 Total Patients Enrolled
704 Trials studying Depression
260,975 Patients Enrolled for Depression
Ronald G Garcia, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have thinking or memory problems due to a head injury.You have had a serious problem with drugs or alcohol in the past year.I have taken medication for mental health issues.I have not had thoughts of suicide or attempted suicide in the past year.You cannot undergo MRI or transcutaneous vagus nerve stimulation (tVNS) if you are claustrophobic or have metallic implants or devices in your body.I have been diagnosed with Major Depressive Disorder more than once.I am not pregnant.I do not have MS, epilepsy, or similar brain diseases.You have a history of a severe mental illness such as schizophrenia or bipolar disorder that involves experiencing hallucinations or delusions.I have a serious heart or blood vessel condition.
Research Study Groups:
This trial has the following groups:- Group 1: Active tVNS
- Group 2: Sham tVNS
Awards:
This trial has 0 awards, including: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.
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