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Behavioural Intervention

VeNS for Post-Traumatic Stress Disorder

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Posttraumatic Stress Disorder Checklist PCL-5 score
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

Clinical Trial MentorsUNKNOWN
3 Previous Clinical Trials
374 Total Patients Enrolled
Neurovalens Ltd.Lead Sponsor
16 Previous Clinical Trials
1,304 Total Patients Enrolled
University of California, San DiegoOTHER
1,130 Previous Clinical Trials
1,552,556 Total Patients Enrolled

Media Library

Modius Spero active device (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05242367 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Active VeNS, Sham VeNS
Post-Traumatic Stress Disorder Clinical Trial 2023: Modius Spero active device Highlights & Side Effects. Trial Name: NCT05242367 — N/A
Modius Spero active device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05242367 — N/A
~47 spots leftby Oct 2024
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