NeuroGlove PTSD Study

PTSD Clinical Trial

Official title:

Impact of Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Post-Traumatic Stress Disorder: Assessing Safety and Effectiveness

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06050590
• Other study ID #: REG-1003
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: NeuroGlove LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	NeuroGlove	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
NeuroGlove LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptom Reduction	Change in PTSD symptoms and subject's sense of well-being	4 weeks
Primary	Portion of participants with adverse events	Rate and severity of adverse events related to the use of the NeuroGlove.	4 weeks
Secondary	PTSD Symptom Severity	Change in severity of symptoms related to PTSD using NSESSS	4 weeks