Post Traumatic Stress DisorderNCT05242367
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for PTSD
A study testing Modius Spero active device in people with Post Traumatic Stress Disorder, run by Neurovalens Ltd. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Modius Spero active device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 383 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 2 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official 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 Post- Traumatic Stress Disorder (PTSD)
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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Modius Spero active device, Sham device
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modius Spero active deviceDevice
Battery powered non-invasive neurostimulation device
Sham deviceDevice
Placebo comparator sham device (no active stimulation)
| Study group | Role | What they receive |
|---|---|---|
| Active VeNS | Active comparator | 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. Receives: Device: Modius Spero active device |
| Sham VeNS | Sham comparator | 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. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start13 Feb 2023
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, Clinical Trial Mentors
- Responsible party
- Sponsor
- Investigators
- Peter Colvonen, MD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242367
- Sponsor's protocol ID
- MS003
- Status last verified
- May 2025
- First submitted
- 9 Feb 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 Post- Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT05242367
- Acronym / sponsor ID
- MS003
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, Clinical Trial Mentors
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active VeNS | Active comparator | Device: Modius Spero active deviceThe 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. |
| Sham VeNS | Sham comparator | Device: Sham deviceThe 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. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modius Spero active deviceBattery powered non-invasive neurostimulation device | Device | Active VeNS |
| Sham devicePlacebo comparator sham device (no active stimulation) | Device | Sham VeNS |
Primary outcome
Posttraumatic Stress Disorder Checklist PCL-5 score
Time frame: 12 weeks
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.
3 secondary outcomes
36-Item Short Form Survey (SF-36) score
Time frame: 12 weeks
Generalised Anxiety Disorder (GAD-7) score
Time frame: 12 weeks
Insomnia Severity Index (ISI) score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Colvonen, MD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modius Spero active device in people with Post Traumatic Stress Disorder, run by Neurovalens Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Disorder Checklist PCL-5 score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.