NeuroGlove PTSD Study

NCT06050590 | Unknown FDA Device

• 1 other identifier: REG-1003
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Post Traumatic Stress Disorder

Keywords

PTSD; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• PTSD Symptom Severity

  4 weeks

Study Arms (1)

NeuroGlove Treatment Arm

EXPERIMENTAL

Study participants undergoing treatment using the NeuroGlove.

Device: NeuroGlove

Interventions

NeuroGlove DEVICE

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

NeuroGlove Treatment Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• NeuroGlove LLC: lead

Study Sites (1)

NeuroGlove

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Eric Nussbaum, MD

  NeuroGlove LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: NeuroGlove

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: September 22, 2023
• Study Start: August 14, 2023
• Primary Completion: August 27, 2024
• Study Completion: September 1, 2024
• Last Updated: August 27, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)