NeuroGlove PTSD Study

Study Overview
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Brief Summary
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This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.

Detailed Description
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This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove. There will be a single cohort in the study consisting of the subjects with PTSD who will receive treatment with NeuroGlove. The trial is intended to evaluate the impact of the device use on active PTSD symptoms and subject sense of well-being.

Official Title
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Impact of Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Post-Traumatic Stress Disorder: Assessing Safety and Effectiveness

Conditions
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PTSD, Post Traumatic Stress Disorder

Intervention / Treatment
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* Device: NeuroGlove


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject. Men and women ≥18 and <85 years of age. Carry an active diagnosis of PTSD. Suffer from PTSD symptoms that impact subject's daily activities and quality of life. Exclusion Criteria: Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.) Subject lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements. Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: NeuroGlove
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroGlove Treatment Arm<br>Study participants undergoing treatment using the NeuroGlove. | Device: NeuroGlove<br>* Study participant with PTSD will undergo daily at home treatment using the NeuroGlove.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptom Reduction | Change in PTSD symptoms and subject's sense of well-being | 4 weeks | 
| Portion of participants with adverse events | Rate and severity of adverse events related to the use of the NeuroGlove. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptom Severity | Change in severity of symptoms related to PTSD using NSESSS | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Post Traumatic Stress Disorder