Modius Spero - A non-invasive, drug-free technology being trialled as a potential treatment for PTSD

Neurovalens is studying the effect of our non-invasive device Modius Spero to treat Post-Traumatic Stress Disorder (PTSD).

Modius Spero is worn on the head for 30 minutes each day and uses a small electrical pulse to stimulate parts of the brain that are associated with PTSD.

Our goal is that Modius Spero can eventually be used as a non-invasive and drug-free treatment for those who struggle with PTSD.

What is PTSD

PTSD is a common psychiatric disorder resulting from exposure to traumatic events such as military conflict, natural disasters, sexual assault, serious car accidents and childbirth.

PTSD affects people worldwide. Research has shown that the prevalence of PTSD can range from 1.3% to 8.8% among adults (1), with these estimates varying depending on the population studied. Many people with PTSD experience symptoms such as:

• Hyper vigilance
• Re-experiencing traumatic events, whether that is through flashbacks, nightmares, or something else
• Irritability or agitation
• Trouble sleeping or insomnia
• Social withdrawal or isolation from others
• Trouble focusing or concentrating
• Difficulty trusting other people
• Emotional detachment
• Feelings of guilt
• Self-destructive behaviours

PTSD is a widespread issue that highlights the need for further research and support for those who have experienced trauma.

Gender Most Affected by PTSD

It is estimated that 6% of the US population will have PTSD at some stage in their lives. While PTSD can affect individuals of any age and gender, research suggests that women are more likely to develop PTSD compared to men. Approximately 8% of women and 4% of men are estimated to experience PTSD at some point in their life (2). This may be because women are more likely to be exposed to trauma such as sexual assault and domestic abuse compared to men, and at a younger age (3).  

Understanding the populations that are more likely to develop PTSD can help with early recognition and treatment, which can improve the outcomes for those affected by the condition.

Overview of The Clinical Trial – The Modius Spero Study

Neurovalens are currently recruiting for a remote clinical trial in the US on the efficacy of the Modius Spero Neurostimulation Device in the management of PTSD.

If you are living with Post-Traumatic Stress Disorder (PTSD), you know how debilitating it can be. From reliving traumatic memories to feeling anxious, living with PTSD can have a major impact on your quality of life. That's why we are excited to announce a new clinical trial that aims to help improve the symptoms of PTSD using electrical vestibular nerve stimulation.

What is Electrical Vestibular Stimulation?

Electrical Vestibular Stimulation is a form of therapy that uses low-level electrical signals to stimulate the vestibular nerve. The stimulation is delivered using the Modius Spero device via electrodes placed on the skin behind both ears. This therapy aims to provide a non-invasive, drug-free treatment that will improve the symptoms of PTSD by influencing the part of the brain that controls your circadian rhythm and sleep patterns.

The Objectives of Our Clinical Trial

The main objective of our clinical trial is to evaluate the Modius Spero device's ability to reduce the severity of PTSD symptoms. To achieve this goal, we are recruiting participants across the US who are living with PTSD.

Participants will be randomly assigned to either receive an active device (treatment) or a sham device (no treatment) to allow us to evaluate the Modius Spero device in improving PTSD symptoms relative to the control group.  

Who Can Participate?

We are actively recruiting adults aged 22 to 80 years living in the USA who have been diagnosed with PTSD. The great news is that this trial is fully remote, so participants can participate from the comfort of their own homes from anywhere in the US.

Benefits of the Clinical Trial

The primary benefit of the trial is to reduce PTSD symptoms and enhance the well-being of individuals living with PTSD. This will be measured through changes in the Post-Traumatic Stress Disorder Checklist (PCL-5) score, which is a self-report questionnaire used to assess the presence and severity of PTSD symptoms. The PCL-5 score can range from 0 to 80, a score of 31 or above indicates probable PTSD. In addition to changes in the PCL-5 score, improvements in insomnia, anxiety and general quality of life will also be monitored.

Additional benefits of this trial are the potential to advance our understanding of PTSD and its treatment. The Modius device has already been shown to be safe and well tolerated across a range of indications, and our trial will help us understand its effectiveness in treating PTSD.

Join our PTSD trial now!

Are you aged 22-80 and living with PTSD? You may be eligible to participate in our study. As a participant, you will receive support throughout the trial. Your participation will help us better understand PTSD and help those living with this condition.

Click here to learn more and to see if you qualify for this trial.