RecruitingNAINTERVENTIONAL

Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study

This study is a first look at a new treatment called trigeminal nerve stimulation (TNS) for people suffering from Generalised Anxiety Disorder (GAD). GAD is a type of anxiety that can be very hard to live with, and some people find that regular medications don't help them enough. This study is for those whose anxiety hasn't responded to at least two different tried-and-tested medications. We’re working with ten participants who will receive TNS for eight weeks, alongside their current medications. The main goal is to check whether TNS is safe and if people can tolerate it well. We will also be watching closely to see if their anxiety symptoms improve. The results of this small study will help us decide if we should do a bigger study in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Dr. Rafael Freire

Enrolment target

Start

18 Jan 2024

Estimated completion

01 Apr 2026

Generalized Anxiety Disorder

What is this study about?

This study is exploring a new approach called trigeminal nerve stimulation, or TNS, for individuals living with Generalised Anxiety Disorder (GAD). GAD is a condition where people experience constant worry and nervousness about many different everyday things, making it hard to relax or concentrate. For some, even with regular medication, their anxiety doesn't get much better. This is sometimes called 'treatment-resistant' anxiety.

In this study, we're looking at whether TNS could be a helpful addition for people who haven't found enough relief from other treatments. TNS involves using a small device that sends gentle electrical pulses to a nerve in your face, called the trigeminal nerve. The idea is that stimulating this nerve might help to calm brain activity linked to anxiety. This is a "feasibility study," which means it's one of the first steps to see if this treatment is generally safe and well-tolerated before we consider a larger study.

We will be carefully observing a small group of participants over eight weeks. Our main goal is to understand if TNS is safe for them and if they can use the device comfortably. We'll also be tracking any changes in their anxiety symptoms to get an early idea of whether the treatment might be beneficial. This initial information will be crucial in planning future research into TNS for anxiety.

Key takeaways

This study explores a new treatment (TNS) for severe anxiety.
It's for people whose anxiety hasn't responded well to usual medications.
The main goal is to check if TNS is safe and well-tolerated.
Participation involves 8 weeks of TNS treatment and symptom monitoring.
Results will help decide if bigger studies should happen in the future.

Who may be eligible?

This study is for adults aged 18 to 65 years old who have been diagnosed with Generalised Anxiety Disorder (GAD). It's specifically for people whose anxiety hasn't improved much after trying at least two different types of medications for a good amount of time and at the right doses. You would also need to be taking a steady dose of an antidepressant medicine (like an SSRI or SNRI) for at least eight weeks before joining.

There are certain reasons why someone might not be able to join the study. For example, if you have other mental health conditions like severe depression, bipolar disorder, schizophrenia, or obsessive-compulsive disorder (OCD). We also can't include people who are pregnant or breastfeeding, have a high risk of harming themselves, or have had seizures. If you have certain medical devices implanted in your body, like a vagal nerve stimulator, or if you're already using a similar electrical nerve stimulation treatment, you wouldn't be able to participate.

We also need to make sure that other factors aren't affecting your anxiety symptoms. This means you shouldn't be regularly using cannabis, illegal drugs, or drinking more than three alcoholic drinks a week. You also shouldn't be taking natural health products that are known to affect anxiety or depression. The aim is to ensure we can clearly see the effects of the TNS treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Do you have a diagnosis of Generalised Anxiety Disorder?
Have at least two different anxiety medications not helped your symptoms enough?
Are you currently on a steady dose of an antidepressant (SSRI/SNRI) for at least 8 weeks?
Are you NOT pregnant or breastfeeding?
Do you NOT have other serious mental health conditions like severe depression or bipolar disorder?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve receiving trigeminal nerve stimulation (TNS) for eight weeks, alongside your current anxiety medication. The specific details of how often and for how long you use the TNS device will be explained by the study team. You would also attend regular appointments and complete assessments to check on your anxiety symptoms and how you are feeling. The total duration of your active participation in receiving the TNS treatment and being monitored would be eight weeks.

Potential risks and benefits

While we cannot promise that you will personally benefit from this study, some participants might find that their anxiety symptoms improve. The main purpose of this study is to check if TNS is a safe treatment. Like any medical approach, there may be potential risks or side effects, which the study team will explain in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Kingston Health Sciences Centre
Verified postcode
Kingston, Canada· Recruiting

Common questions

What is trigeminal nerve stimulation (TNS)?

TNS is a new treatment that uses a small device to send mild electrical pulses to a nerve in your face, which we hope might help with anxiety.

Who is this study for?

It's for adults (18-65) with Generalised Anxiety Disorder whose anxiety hasn't improved much with at least two different anxiety medications.

How long does the study last?

If you take part, you'll receive the TNS treatment and be monitored for eight weeks.

Will this study cure my anxiety?

This is a small, early study to see if TNS is safe and might help. We can't promise a cure, but we hope to learn if it could be a useful treatment.

Can I stop taking part if I change my mind?

Yes, you are free to leave the study at any point, and your medical care will not be affected.

How to find out more

Yan Deng

yan.deng@queensu.ca +1 613-548-7839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.