Post Traumatic Stress Disorder, PTSD
Conditions
Keywords
PTSD, Post Traumatic Stress Disorder
Brief summary
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
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.
Interventions
DEVICENeuroGlove
Study participant with PTSD will undergo daily at home treatment using the NeuroGlove.
Sponsors
NeuroGlove LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
NeuroGlove
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptom Reduction | 4 weeks | Change in PTSD symptoms and subject's sense of well-being |
| Portion of participants with adverse events | 4 weeks | Rate and severity of adverse events related to the use of the NeuroGlove. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptom Severity | 4 weeks | Change in severity of symptoms related to PTSD using NSESSS |
Countries
United States
Outcome results
None listed