Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for PTSD

Study Overview
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Brief Summary
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Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of PTSD The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating PTSD, as compared to a sham control. Allocation: Randomized to either active device or control device usage. Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation Sample size: The aim is to recruit a total of up to 200 participants. The study will last 12 weeks in total for each subject.

Official Title
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A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Post- Traumatic Stress Disorder (PTSD)

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Device: Modius Spero active device
* Device: Sham device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Diagnosed PTSD by a medical practitioner Post-Traumatic Checklist (PCL-5) score or 31 or above Eligibility confirmed via the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Male or female, age ≥ 22 years and ≤ 80 years at the time of signing informed consent Ability and willingness to complete all study visits and procedures, including completion of mental health questionnaires Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the trial Agreement not to start any new PTSD, mental health, or insomnia medications for the duration of the trial and/or to inform the study team if intending on starting any new PTSD, mental health, or insomnia medications Agreement not to change any PTSD specific treatments for the duration of the trial e.g cognitive processing therapy Agreement not to undergo any significant lifestyle changes that may affect sleep (e.g. excessive exercise, sleep interventions etc.) for the duration of the trial Agreement not to use sleep trackers (e.g. Fitbit) for the duration of the trial Agreement not to travel across different time zones for the duration of the trial Access to Wi-Fi (for app to be able to upload usage data) Access to computer, laptop, iPad or tablet (to conduct remote study visits and complete study questionnaires remotely) Screening review by PTSD physician (study PI) Willingness to download and use a video platform (e.g Zoom) to conduct remote study visits Willingness to engage weekly with your Clinical Trial Mentor (CTM) Exclusion Criteria: History of skin breakdown, eczema, or other dermatological condition (e.g., psoriasis) affecting the skin behind the ears History of severe tinnitus or vertigo History or presence of malignancy within the last year Use of beta-blockers within 1 month of starting the study History of chronic viral infection that causes vestibular neuropathy (e.g., hepatitis or HIV) Use of antihistamines A history of stroke or severe head injury as defined by a head injury that required a craniotomy or endotracheal intubation (in case this damaged the neurological pathways involved in vestibular stimulation) Taking H2-receptor antagonist medication Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.) Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method Diagnosis of epilepsy Diagnosis of active migraines Previous use of Modius device Participation in other research studies sponsored by Neurovalens Participation in any other PTSD studies Not fluent in English language Have a member of the same household who is currently participating in this study Failure to agree to use of device daily during study participation Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active VeNS<br> | Device: Modius Spero active device<br>* Battery powered non-invasive neurostimulation device<br>|
| Sham Comparator: Sham VeNS<br> | Device: Sham device<br>* Placebo comparator sham device (no active stimulation)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder Checklist PCL-5 score | To evaluate the effect of the Modius Sleep device, relative to control group, on the symptoms of PTSD, quantified by change in the PCL-5 Score. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 36-Item Short Form Survey (SF-36) score | To evaluate the effect of the Modius Spero device, relative to control group, on quality of life quantified by change in SF-36 score. | 12 weeks | 
| Generalised Anxiety Disorder (GAD-7) score | To evaluate the effect of the Modius Spero device, relative to control group, on anxiety, quantified by change in the GAD-7 score. GAD-7 is a self-report rating scale assessing the severity of anxiety (range 0-21), with higher score indicating more severe anxiety. | 12 weeks | 
| Insomnia Severity Index (ISI) score | To evaluate the effect of the Modius Spero device, relative to control group, on participants with insomnia. ISI is a self-report rating scale assessing the severity of insomnia symptoms (range 0-28) with higher scores indicating a more severe insomnia. | 12 weeks |