NeuroGlove PTSD Study

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

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.

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.

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.)