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NeuroGlove PTSD Study

N

NeuroGlove

Status

Active, not recruiting

Conditions

Post Traumatic Stress Disorder
PTSD

Treatments

Device: NeuroGlove

Study type

Interventional

Funder types

Industry

Identifiers

NCT06050590
REG-1003

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

NeuroGlove Treatment Arm
Experimental group
Description:
Study participants undergoing treatment using the NeuroGlove.
Treatment:
Device: NeuroGlove

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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