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Behavioural Intervention

VeNS for Post-Traumatic Stress Disorder

N/A

Waitlist Available

Led By Peter Colvonen, MD

Research Sponsored by Neurovalens Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, age ≥ 22 years and ≤ 80 years at the time of signing informed consent

Agreement not to change any PTSD specific treatments for the duration of the trial e.g cognitive processing therapy

Must not have

History of chronic viral infection that causes vestibular neuropathy (e.g., hepatitis or HIV)

History of skin breakdown, eczema, or other dermatological condition (e.g., psoriasis) affecting the skin behind the ears

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial aims to measure how well non-invasive electrical vestibular nerve stimulation (VeNS) treats PTSD compared to a sham control. 200 participants will be recruited and monitored over 12 weeks.

Who is the study for?

Adults aged 22-80 with diagnosed PTSD, a PCL-5 score of at least 31, and confirmed eligibility via CAPS-5 can join. Participants must not change their PTSD treatments or start new medications during the trial, avoid significant lifestyle changes affecting sleep, refrain from using sleep trackers or traveling across time zones, have Wi-Fi access for data upload, and be willing to use the device daily for 30 minutes.

What is being tested?

The study is testing if a non-invasive electrical stimulation device (Modius Spero) can help treat PTSD compared to a sham (fake) device. Participants will be randomly assigned to either the active device group or control group in equal numbers and will use it daily for 12 weeks.

What are the potential side effects?

Potential side effects are not specified but may include skin irritation behind the ears due to device usage. People with certain conditions like severe tinnitus or vertigo were excluded which suggests these could be exacerbated by VeNS.

Eligibility Criteria

Inclusion Criteria

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

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I am between 22 and 80 years old.

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I agree not to change my PTSD treatments during the trial.

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I have been diagnosed with PTSD by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a long-term viral infection like hepatitis or HIV affecting my balance.

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I have a history of skin issues like eczema or psoriasis, especially behind my ears.

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I am not fluent in English.

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I am pregnant, breastfeeding, planning to become pregnant, or not using birth control.

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I am taking medication for stomach acid.

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I have been diagnosed with active migraines.

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I have had cancer within the last year.

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I have had a stroke or severe head injury needing surgery or intubation.

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I have been diagnosed with epilepsy.

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I have a history of severe ringing in my ears or dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Posttraumatic Stress Disorder Checklist PCL-5 score

Secondary study objectives

36-Item Short Form Survey (SF-36) score

Generalised Anxiety Disorder (GAD-7) score

Insomnia Severity Index (ISI) score

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active VeNSActive Control1 Intervention

The active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.

Group II: Sham VeNSPlacebo Group1 Intervention

The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.

0 / 13Eligibility criteria met