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Behavioural Intervention

Trigeminal Nerve Stimulation for Generalized Anxiety Disorder

N/A

Recruiting

Led By Rafael Freire, MD PhD

Research Sponsored by Dr. Rafael Freire

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Moderate to severe major depressive disorder

Participants who are experiencing seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-week visit and 8-week visit.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the use of trigeminal nerve stimulation (TNS) in patients with severe anxiety that doesn't respond to standard treatment. Ten patients will receive TNS for 8 weeks

Who is the study for?

This trial is for individuals with generalized anxiety disorder (GAD) who haven't had success with standard treatments. It's a small study, aiming to include just ten participants.

What is being tested?

The study is testing trigeminal nerve stimulation (TNS) as an add-on to usual drug treatment for GAD over 8 weeks. The main goal is to check if TNS is safe and tolerable, while also watching for any changes in the severity of anxiety symptoms.

What are the potential side effects?

Since this is a feasibility study, part of its purpose is to identify potential side effects of TNS. However, common side effects might include discomfort at the stimulation site or headaches.

Eligibility Criteria

Exclusion Criteria

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

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I have been diagnosed with major depression that is moderate to severe.

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I am currently experiencing seizures.

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I am currently receiving electrical nerve stimulation therapy.

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I do not use cannabis, its by-products, illicit drugs, or consume more than 3 alcoholic drinks per week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-week visit and 8-week visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-week visit and 8-week visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-week visit and 8-week visit. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of treatment-emergent adverse events

Incidence of treatment-emergent side effects measured with the NSEC

Response to treatment defined by CGI-I score below 3

Secondary study objectives

Change in anxiety severity measured by CGI-S

Change of anxiety symptoms measured with BAI

Change of anxiety symptoms measured with GAD-7

+2 more

Side effects data

From 2011 Phase 2 trial • 50 Patients • NCT01159431

16%

skin irritation

Anxiety

100%

80%

60%

40%

20%

Study treatment Arm

Active

Control

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Active stimulationExperimental Treatment1 Intervention

Trigeminal nerve stimulation will occur by placement of electrodes (1.25" silver electrodes Bio-Flex BF4, Biotens/Vermed, Buffalo, New York, USA) bilaterally on the V1 branches of the trigeminal nerve (CNV) located on the forehead. Current will be generated from the EMS 7500 stimulator (TENS Products, Inc., Granby, CO) (Class II medical device) and will be set to a level that is clearly perceptible by each patient (i.e. tingling sensation) but not uncomfortable or painful. Current level will be determined for each patient at baseline and will likely be between 4-6 milliampere (mA). Active stimulation will occur at 120 Hz with a 250 μs pulse width and with a duty cycle of 30 seconds on to 30 seconds off.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trigeminal Nerve Stimulation

2011

Completed Phase 2

~150

0 / 4Eligibility criteria met