NeuroGlove PTSD Study

NCT ID: NCT06050590

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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PTSD Post Traumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

NeuroGlove
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NeuroGlove Treatment Arm

Study participants undergoing treatment using the NeuroGlove.

Group Type EXPERIMENTAL

NeuroGlove

Intervention Type DEVICE

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

Interventions

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NeuroGlove

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

Intervention Type DEVICE

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NeuroGlove LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Nussbaum, MD

Role: PRINCIPAL_INVESTIGATOR

NeuroGlove LLC

Locations

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NeuroGlove

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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REG-1003

Identifier Type: -

Identifier Source: org_study_id

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