NeuroGlove PTSD Study | NCT06050590

Studies
NeuroGlove PTSD Study

NCT06050590

Sponsor

NeuroGlove LLC

Status

Unknown status

Last Update Posted

Aug 27, 2024Actual

Enrollment

6Estimated

Phase

Not Applicable

Conditions

PTSD
Post Traumatic Stress Disorder

Interventions

NeuroGlove

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2023Actual

Primary Completion Date

Aug 27, 2024Estimated

Completion Date

Sep 1, 2024Estimated

First Submitted Date

Jul 17, 2023

First Submission Date that Met QC Criteria

Sep 21, 2023

First Posted Date

Sep 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2024

Last Update Posted Date

Aug 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NeuroGlove Treatment Arm	Experimental	Study participants undergoing treatment using the NeuroGlove.	Device: NeuroGlove

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NeuroGlove	Device	Study participant with PTSD will undergo daily at home treatment using the NeuroGlove.	NeuroGlove Treatment Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Nussbaum, MD	NeuroGlove LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NeuroGlove		Saint Paul	Minnesota	55102	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided