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)

Neurovalens Ltd.1 site in 1 country383 target enrollmentFebruary 13, 2023

ConditionsPost Traumatic Stress Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Post Traumatic Stress Disorder
Sponsor: Neurovalens Ltd.
Enrollment: 383
Locations: 1
Primary Endpoint: Posttraumatic Stress Disorder Checklist PCL-5 score
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 13, 2023

End Date

December 2, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Neurovalens Ltd.

Responsible Party

Sponsor

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

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