NeuroGlove PTSD Study

September 21, 2023 updated by: NeuroGlove LLC

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • NeuroGlove

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeuroGlove Treatment Arm
Study participants undergoing treatment using the NeuroGlove.
Device: NeuroGlove
Study participant with PTSD will undergo daily at home treatment using the NeuroGlove.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Symptom Severity
Time Frame: 4 weeks
Change in severity of symptoms related to PTSD using NSESSS
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroGlove LLC

Investigators

  • Principal Investigator: Eric Nussbaum, MD, NeuroGlove LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-1003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will only be used by the sponsor organization and investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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