Back to resultsNeuroGlove PTSD Study
Primary Purpose
PTSD, Post Traumatic Stress Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeuroGlove
Sponsored by
About this trial
This is an interventional treatment trial for PTSD focused on measuring PTSD, Post Traumatic Stress Disorder
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.)
Sites / Locations
- NeuroGlove
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NeuroGlove Treatment Arm
Arm Description
Study participants undergoing treatment using the NeuroGlove.
Outcomes
Primary Outcome Measures
PTSD Symptom Reduction
Change in PTSD symptoms and subject's sense of well-being
Portion of participants with adverse events
Rate and severity of adverse events related to the use of the NeuroGlove.
Secondary Outcome Measures
PTSD Symptom Severity
Change in severity of symptoms related to PTSD using NSESSS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06050590
Brief Title
NeuroGlove PTSD Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroGlove LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Post Traumatic Stress Disorder
Keywords
PTSD, Post Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
NeuroGlove
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NeuroGlove Treatment Arm
Arm Type
Experimental
Arm Description
Study participants undergoing treatment using the NeuroGlove.
Intervention Type
Device
Intervention Name(s)
NeuroGlove
Intervention Description
Study participant with PTSD will undergo daily at home treatment using the NeuroGlove.
Primary Outcome Measure Information:
Title
PTSD Symptom Reduction
Description
Change in PTSD symptoms and subject's sense of well-being
Time Frame
4 weeks
Title
Portion of participants with adverse events
Description
Rate and severity of adverse events related to the use of the NeuroGlove.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
PTSD Symptom Severity
Description
Change in severity of symptoms related to PTSD using NSESSS
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Nussbaum, MD
Organizational Affiliation
NeuroGlove LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
NeuroGlove
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data will only be used by the sponsor organization and investigators.
Learn more about this trial
NeuroGlove PTSD Study
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