NeuroGlove PTSD Study

Not Applicable

Active, not recruiting

• Conditions: PTSD; Post Traumatic Stress Disorder
• Interventions: Device: NeuroGlove

• Registration Number: NCT06050590
• Lead Sponsor: NeuroGlove LLC

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.

Study Timeline

• Study First Submitted: 2023-07-17
• Study Start: 2023-08-14
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-22
• Last Update Submitted: 2024-08-26
• Primary Completion: 2024-08-27
• Last Update Posted: 2024-08-27
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeuroGlove Treatment Arm	NeuroGlove	Study participants undergoing treatment using the NeuroGlove.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
PTSD Symptom Severity	4 weeks	Change in severity of symptoms related to PTSD using NSESSS

Trial Locations

Locations (1)

NeuroGlove; 🇺🇸 Saint Paul, Minnesota, United States