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Vagus Nerve Stimulation

Vagal Nerve Stimulation for Major Depressive Disorder

N/A

Waitlist Available

Led By Matthew Macaluso, M.D.

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Age 18-75 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is testing whether electrical stimulation of the vagus nerve, using a handheld device, can help treat depression and whether it is safe to use.

Who is the study for?

This trial is for adults aged 18-75 with Major Depressive Disorder (MDD), confirmed by specific diagnostic criteria, who speak English and have a significant level of depression. Excluded are those at immediate suicide risk, with certain neurological diseases or head injuries, recent mothers, pregnant or lactating women, patients with carotid artery narrowing or vagus nerve surgery history, substance abuse issues within the last three months, other primary psychiatric disorders besides MDD, and various autoimmune conditions.Check my eligibility

What is being tested?

The study tests if gammaCore™—a non-invasive handheld device that stimulates the vagal nerve—can effectively treat major depression. It also aims to confirm the safety profile of this treatment method.See study design

What are the potential side effects?

While not explicitly listed in your information provided, typical side effects from similar non-invasive vagal nerve stimulation devices may include headache, neck pain or discomfort where the device is used; tingling sensations; skin irritation; and muscle twitching.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Antidepressant effects of nVNS in humans

Incidence of gammaCore™ Adverse Events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention GroupExperimental Treatment1 Intervention

Treatment effects will be measured using standard rating scales including the HDRS-17, MADRS, SF-36, CSSR-S, CGI-I, CGI-S, which will be completed at each visit. The following scales will be completed at every other visit following the screening visit: Social Anhedonia Scale, the Motivation and Energy Inventory and the Physical Anhedonia Scale. At each study visit safety assessments including vital sign assessment and adverse event assessment will be completed. Subjects will also undergo physical examination and an ECG for safety during screening, after 8 weeks of treatment and at the end of 12 weeks of treatment.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,583 Previous Clinical Trials

2,280,039 Total Patients Enrolled

24 Trials studying Depression

2,629 Patients Enrolled for Depression

Matthew Macaluso, M.D.Principal InvestigatorThe University of Alabama at Birmingham

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment capacity for this experiment?

"Affirmative, the information posted on clinicaltrials.gov reveals that this trial is actively seeking volunteers. It was initially made available to the public on January 1st 2022 and has been revised as recently as January 26th 2022. The research project needs 5 people at one site for participation."

Answered by AI

Are there still openings available for this clinical research program?

"Indeed, clinicaltrials.gov displays that this ongoing medical trial is seeking participants. This study was originally posted on January 1st 2022 and recently amended on January 26th 2022; it requires five people from a single site."

Answered by AI

Does this research endeavor include elderly individuals as participants?

"To be considered for this clinical trial, applicants must fall between 18 and 75 years of age."

Answered by AI

To whom does this experiment extend an invitation?

"In order to qualify for inclusion in this experiment, individuals must have melancholia and be between 18-75 years old. The researchers are looking to recruit 5 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vagal Nerve Stimulation for Treatment Resistant Major Depression

Matthew Macaluso 2022. "Vagal Nerve Stimulation for Treatment Resistant Major Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04990687.