Clinical trial NCT05242367: Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for PTSD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Neurovalens Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Diego
name: Clinical Trial Mentors
First posted: 2022-02-16
Enrollment: 383
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Posttraumatic Stress Disorder Checklist PCL-5 score
timeFrame: 12 weeks
Secondary outcomes:
measure: 36-Item Short Form Survey (SF-36) score
timeFrame: 12 weeks
measure: Generalised Anxiety Disorder (GAD-7) score
timeFrame: 12 weeks
measure: Insomnia Severity Index (ISI) score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: UC San Diego
name: Peter Colvonen, MD
role: PRINCIPAL_INVESTIGATOR
References: