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NeuroGlove PTSD Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06050590
Recruitment Status : Active, not recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
NeuroGlove LLC

Tracking Information
First Submitted Date  ICMJE July 17, 2023
First Posted Date  ICMJE September 22, 2023
Last Update Posted Date September 22, 2023
Actual Study Start Date  ICMJE August 14, 2023
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2023)
  • PTSD Symptom Reduction [ Time Frame: 4 weeks ]
    Change in PTSD symptoms and subject's sense of well-being
  • Portion of participants with adverse events [ Time Frame: 4 weeks ]
    Rate and severity of adverse events related to the use of the NeuroGlove.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2023)		 PTSD Symptom Severity [ Time Frame: 4 weeks ]
Change in severity of symptoms related to PTSD using NSESSS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NeuroGlove PTSD Study
Official Title  ICMJE Impact of Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Post-Traumatic Stress Disorder: Assessing Safety and Effectiveness
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
NeuroGlove
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • PTSD
  • Post Traumatic Stress Disorder
Intervention  ICMJE Device: NeuroGlove
Study participant with PTSD will undergo daily at home treatment using the NeuroGlove.
Study Arms  ICMJE Experimental: NeuroGlove Treatment Arm
Study participants undergoing treatment using the NeuroGlove.
Intervention: Device: NeuroGlove
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2023)		 6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2024
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06050590
Other Study ID Numbers  ICMJE REG-1003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The data will only be used by the sponsor organization and investigators.
Current Responsible Party NeuroGlove LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE NeuroGlove LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Nussbaum, MD NeuroGlove LLC
PRS Account NeuroGlove LLC
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP