Trigeminal Nerve Stimulation for Anxiety Disorders

YD
RM
Overseen ByRoumen Milev, MD PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking medications for anxiety disorders, antidepressants, and benzodiazepines to participate in this trial.

What data supports the effectiveness of the treatment Trigeminal Nerve Stimulation for anxiety disorders?

Research suggests that external trigeminal nerve stimulation (eTNS) is safe and may improve mood, as seen in studies with epilepsy and depression. It has shown potential in reducing seizure frequency and improving mood, which could indicate benefits for anxiety as well.12345

Is trigeminal nerve stimulation (TNS) safe for humans?

Research on trigeminal nerve stimulation (TNS) for epilepsy shows it is generally safe and well tolerated in humans, with no significant issues related to heart rate or blood pressure.12346

How does trigeminal nerve stimulation treatment differ from other treatments for anxiety disorders?

Trigeminal nerve stimulation (TNS) is unique because it is a non-invasive treatment that uses external electrodes to stimulate the trigeminal nerve, which may influence brain areas involved in mood and anxiety regulation. Unlike traditional medications, TNS does not involve taking drugs and has shown promise in improving mood and anxiety in conditions like epilepsy and depression.12357

What is the purpose of this trial?

This trial is testing a treatment called trigeminal nerve stimulation, which involves sending electrical signals to a nerve in the face. It aims to help patients with panic disorder, generalized anxiety disorder, and social anxiety disorder. The treatment works by calming brain activity to reduce anxiety symptoms. Trigeminal nerve stimulation (TNS) is a promising strategy in treating diseases of the nervous system, including epilepsy and traumatic brain injury.

Research Team

RF

Rafael Freire, MD PhD

Principal Investigator

Department of Psychiatry, Queen's University

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with panic, social anxiety, or generalized anxiety disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trigeminal nerve stimulation or sham stimulation at home for 8 hours per night, 7 days a week for 8 weeks

8 weeks

Follow-up

Participants are monitored for sustained response and remission two weeks after the end of treatment

2 weeks

Treatment Details

Interventions

  • Trigeminal Nerve Stimulation
Trial Overview 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.
Participant Groups
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.

Trigeminal Nerve Stimulation is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Monarch eTNS System for:
  • Attention Deficit Hyperactivity Disorder (ADHD) in children aged 7-12
🇪🇺
Approved in European Union as Cefaly for:
  • Migraine prevention and treatment

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dr. Rafael Freire

Lead Sponsor

Trials
2
Recruited
10+

Dr. Rafael Freire

Lead Sponsor

Trials
2
Recruited
10+

Findings from Research

External trigeminal nerve stimulation (eTNS) is a safe and well-tolerated therapy for patients with drug-resistant epilepsy, as shown in a pilot feasibility study.
The study specifically monitored heart rate and blood pressure responses to eTNS, indicating no significant adverse effects on these vital signs.
Acute and long-term safety of external trigeminal nerve stimulation for drug-resistant epilepsy.Pop, J., Murray, D., Markovic, D., et al.[2011]
In a study of 42 patients with drug refractory epilepsy, external trigeminal nerve stimulation (eTNS) showed a significant improvement in quality of life and mood for patients without intellectual disabilities, suggesting its potential benefits beyond seizure control.
While there was a decrease in seizure frequency of 11% among participants, this change was not statistically significant, indicating that more controlled studies are needed to fully assess the efficacy of eTNS as a treatment option.
An audit of external trigeminal nerve stimulation (eTNS) in epilepsy.Slaght, SJ., Nashef, L.[2018]
External trigeminal nerve stimulation (ETNS) significantly reduced seizure frequency in patients with focal drug-resistant epilepsy (DRE), with a 50% response rate compared to 0% in the control group after 12 months.
ETNS was well-tolerated with no relevant adverse events, and it improved quality of life without affecting mood or cognitive function, indicating its potential as a safe long-term treatment option.
External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial.Gil-López, F., Boget, T., Manzanares, I., et al.[2021]

References

Acute and long-term safety of external trigeminal nerve stimulation for drug-resistant epilepsy. [2011]
An audit of external trigeminal nerve stimulation (eTNS) in epilepsy. [2018]
External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial. [2021]
Pilot study of trigeminal nerve stimulation (TNS) for epilepsy: a proof-of-concept trial. [2006]
Trigeminal Nerve Stimulation for Comorbid Posttraumatic Stress Disorder and Major Depressive Disorder. [2022]
The Effectiveness of Trigeminal Nerve Stimulation on Traumatic Brain Injury. [2023]
A prospective long-term study of external trigeminal nerve stimulation for drug-resistant epilepsy. [2018]
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