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Neurostimulation

Trigeminal nerve stimulation - active for Panic Disorder

N/A
Waitlist Available
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
Meet DSM5 criteria for panic disorder, social anxiety disorder or generalized anxiety disorder.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up clinical global impression - severity scale (cgi-s) will be administered two weeks after the end of the treatment.
Awards & highlights

Study Summary

This trial is testing if a new treatment, trigeminal nerve stimulation, is effective and tolerated well by patients with different types of anxiety disorders.

Who is the study for?
This trial is for individuals who have been diagnosed with panic disorder, social anxiety disorder, or generalized anxiety disorder according to DSM5 criteria. It's not specified who can't join the trial.Check my eligibility
What is being tested?
The study is testing trigeminal nerve stimulation (TNS) as a treatment for various anxiety disorders. Participants will receive either active TNS or a sham (placebo) version to compare effectiveness and tolerability.See study design
What are the potential side effects?
While specific side effects are not listed, TNS is generally considered low-risk. Potential side effects might include discomfort at the stimulation site or mild headaches.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~clinical global impression - improvement scale (cgi-i) will be administered two weeks after the end of the treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and clinical global impression - improvement scale (cgi-i) will be administered two weeks after the end of the treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Remission
Response
Secondary outcome measures
Functioning
Generalized anxiety disorder symptoms
Panic disorder symptoms
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active stimulationExperimental Treatment1 Intervention
Active or sham TNS treatment will be performed at the patients' home for approximately 8 hours per night 7 days a week for 8 consecutive weeks. Trigeminal nerve stimulation will occur by placement of electrodes (1.25" silver electrodes Bio-Flex BF4, Biotens/Vermed, Buffalo, NY, 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 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.
Group II: Sham stimulationPlacebo Group1 Intervention
Active or sham TNS treatment will be performed at the patients' home for approximately 8 hours per night 7 days a week for 8 consecutive weeks. Sham stimulation will occur by placement of electrodes (1.25" silver electrodes Bio-Flex BF4, Biotens/Vermed, Buffalo, NY, 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 mA. Sham stimulation will use the same parameters of active stimulation, but after 60 seconds the stimulator will turn off.

Find a Location

Who is running the clinical trial?

Dr. Rafael FreireLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Rafael Freire, MD PhDPrincipal InvestigatorDepartment of Psychiatry, Queen's University
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

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

What is the upper limit of participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov corroborates that this investigation is actively seeking participants, which was initially publicized on February 7th 2022 and later modified on April 20th 2022. Sixty two individuals are sought at one site for the trial."

Answered by AI

Is eligibility for this trial limited to persons below a certain age limit?

"According to the parameters for admission, only individuals between 18 and 65 years of age can apply. Individuals younger than 18 have access to 326 clinical trials whilst those above 65 are eligible for 828 different medical studies."

Answered by AI

Does this research endeavor seek to enlist patient participants?

"According to the details posted on clinicaltrials.gov, this is an active recruitment trial which was initially advertised on February 7th 2022 and updated as recently as April 20th 2022."

Answered by AI

Who is eligible to participate in the trial?

"In order to be considered for this trial, individuals must have panic attacks and meet the age criteria of between 18 - 65 years old. Approximately 62 people are accepted into the clinical phase."

Answered by AI

What is the desired outcome of this clinical trial?

"This trial shall be monitored over the span of 8 weeks, its overarching purpose being to gauge patient response using a Clinical Global Impression - Severity scale (CGI-S). Secondarily, researchers will measure Generalized Anxiety Disorder symptoms with the aid of a Generalized Anxiety Disorder 7-item scale (GAD-7), Social Phobia Inventory's score range from 0 to 68 indicating severity and Sustained Response on a Clinical Global Impression - Improvement scale (CGI-I) ranging from 0 to 7."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
What state do they live in?
Alabama

Why did patients apply to this trial?

I am a medical student close to the finish line and I am really interested to research in this area. Also, I have in fact tried medication plus therapy and still experience pretty bad episodes, benzodiazepines are not effective on me and my sleep is pretty impaired still.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is there a placebo group? if so how may compared to the totality? How is blinding achieved successfully?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation
Dr. Rafael Freire 2022. "Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04931134.
All > Anxiety Disorder
~0 spots leftby Dec 2024
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