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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 belowSelect...
I am between 22 and 80 years old.
Select...
I agree not to change my PTSD treatments during the trial.
Select...
I have been diagnosed with PTSD by a doctor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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.
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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
1,120 Previous Clinical Trials
1,521,107 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to start new mental health medications during the trial without informing the study team.I have a long-term viral infection like hepatitis or HIV affecting my balance.I have a history of skin issues like eczema or psoriasis, especially behind my ears.I have not taken beta-blockers in the last month.I am not fluent in English.I am pregnant, breastfeeding, planning to become pregnant, or not using birth control.I am taking medication for stomach acid.I have been diagnosed with active migraines.I am willing to meet weekly with my Clinical Trial Mentor.I have had cancer within the last year.I am between 22 and 80 years old.I agree not to change my PTSD treatments during the trial.I have had a stroke or severe head injury needing surgery or intubation.I am currently taking antihistamines.I have been diagnosed with epilepsy.I have been diagnosed with PTSD by a doctor.I have a history of severe ringing in my ears or dizziness.
Research Study Groups:
This trial has the following groups:- Group 1: Active VeNS
- Group 2: Sham VeNS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants aged 25 or older eligible to join this research project?
"This trial has set an age range of 22 to 80 years old as its parameters for patient eligibility."
Answered by AI
What criteria must prospective participants meet to be accepted for this clinical trial?
"This trial, which has a planned enrollment of 200 participants, welcomes those aged between 22 and 80 who are currently suffering from post traumatic stress disorder."
Answered by AI
How many individuals are taking part in the experiment?
"Affirmative. Clinicaltrials.gov data confirms that this clinical trial, first publicized on February 13th 2023, is actively searching for candidates to participate. 200 patients are sought after at 1 specified medical centre."
Answered by AI
Are there any remaining vacancies for participants in this medical experiment?
"Indeed, the clinical trial is currently seeking 200 participants at a single medical site. As of February 21st 2023, per information on clinicaltrials.gov this study has been active since its initial posting on February 13th 2023."
Answered by AI
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