Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Neurovalens Ltd.
With
University of California, San Diego
Clinical Trial Mentors
Age
22–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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.
Clareo Health | Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for PTSD
