VeNS for Post-Traumatic Stress Disorder

Recruiting in Palo Alto (17 mi)

Overseen byPeter Colvonen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Neurovalens Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 400 participants. The study will last 12 weeks in total for each subject.

Research Team

Peter Colvonen, MD

Principal Investigator

UC San Diego

Eligibility Criteria

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.

Inclusion Criteria

I agree not to start new mental health medications during the trial without informing the study team.

I am willing to meet weekly with my Clinical Trial Mentor.

Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the trial

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Exclusion Criteria

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

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

Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.)

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Treatment Details

Interventions

Modius Spero active device (Behavioural Intervention)
Modius Spero sham device (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.