NeuroGlove PTSD Study

NeuroGlove LLC6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PTSD Post Traumatic Stress Disorder

Interventions

NeuroGloveDEVICE

Study participant with PTSD will undergo daily at home treatment using the NeuroGlove.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.)

Locations (1)

NeuroGlove

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

PTSD Symptom Reduction

Change in PTSD symptoms and subject's sense of well-being

Time frame: 4 weeks

Portion of participants with adverse events

Rate and severity of adverse events related to the use of the NeuroGlove.

Time frame: 4 weeks

Secondary Outcomes

PTSD Symptom Severity

Change in severity of symptoms related to PTSD using NSESSS

Time frame: 4 weeks

Data from ClinicalTrials.gov

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