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Behavioural Intervention

Active 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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 outcome measures

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dr. Rafael FreireLead Sponsor

1 Previous Clinical Trials

1 Total Patients Enrolled

1 Trials studying Generalized Anxiety Disorder

1 Patients Enrolled for Generalized Anxiety Disorder

Rafael Freire, MD PhDPrincipal InvestigatorDepartment of Psychiatry, Queen's University

1 Previous Clinical Trials

1 Total Patients Enrolled

1 Trials studying Generalized Anxiety Disorder

1 Patients Enrolled for Generalized Anxiety Disorder

Frequently Asked Questions

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

Do I meet the necessary qualifications to be enrolled in this research trial?

"Individuals with generalized anxiety disorder aged between 18 and 65 are eligible to participate in this research. A total of 10 participants will be enrolled in the study."

Answered by AI

Is this medical study currently accepting participants for enrollment?

"Indeed, as per the details on clinicaltrials.gov, this study is actively enrolling subjects. The trial was initially listed on January 18th, 2024 and recently updated on February 23rd, 2024. Recruitment aims to secure 10 participants from a single site."

Answered by AI

What is the current number of participants eligible for enrollment in this clinical research study?

"Indeed, the information available on clinicaltrials.gov highlights that this research initiative is actively seeking suitable candidates. The study was initially posted on January 18th, 2024 and last updated on February 23rd, 2024. Enrollment targets include recruiting 10 participants from a single designated site."

Answered by AI