Back to resultsNeuroGlove Anxiety and Depression Study
Primary Purpose
Anxiety, Depression, Anxiety Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NeuroGlove
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Depression
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 anxiety and/or depression. Suffer from anxiety and/or depression 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.) The 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NeuroGlove Treatment Arm
Arm Description
Subjects will receive treatment using the NeuroGlove. The treatment regimen at home will include 1 hour of therapy per day (two 30-minute sessions, one using each hand) for 4 weeks.
Outcomes
Primary Outcome Measures
Change in anxiety symptoms using GAD-7
The change in symptoms pertaining to anxiety will be evaluated using the change in the GAD-7 score. The GAD-7 is a general anxiety questionnaire with 7 questions. The score ranges from 0 - no anxiety to 21 - severe anxiety.
Change in depression symptoms using PHQ-9
The change in symptoms pertaining to depression will be evaluated using the change in the PHQ-9 score. The PHQ-9 is a general anxiety questionnaire with 9 questions. What does a PHQ-9 score mean? Scores less than 5 often signify the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression; depression scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.
Rate of Adverse Events
Rate and severity of adverse events related to the use of the NeuroGlove assessed by PI during patient interview.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06065787
Brief Title
NeuroGlove Anxiety and Depression Study
Official Title
Impact of Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Anxiety and Depression: Assessing Safety and Effectiveness
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
November 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
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, homebased, interventional clinical study containing 10 subjects who will be enrolled. Approximately 10 (10) subjects with active anxiety and depression symptoms will receive treatment using the NeuroGlove.
Detailed Description
This is a prospective, homebased, interventional clinical study containing 10 subjects who will be enrolled. Approximately 10 (10) subjects with active anxiety and depression symptoms will receive treatment using the NeuroGlove.
Subjects will be recruited in from the community. Inclusion in the study will not impact the care management of the subject. Informed consent will be obtained from all subjects before inclusion in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Anxiety Depression, Depression, Anxiety
Keywords
Anxiety, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NeuroGlove Treatment Arm
Arm Type
Experimental
Arm Description
Subjects will receive treatment using the NeuroGlove. The treatment regimen at home will include 1 hour of therapy per day (two 30-minute sessions, one using each hand) for 4 weeks.
Intervention Type
Device
Intervention Name(s)
NeuroGlove
Intervention Description
The NeuroGlove is intended to provide peripheral sensory stimulation to the hand through pneumatic puffs of air to encourage collateral blood supply and sensorimotor development.
Primary Outcome Measure Information:
Title
Change in anxiety symptoms using GAD-7
Description
The change in symptoms pertaining to anxiety will be evaluated using the change in the GAD-7 score. The GAD-7 is a general anxiety questionnaire with 7 questions. The score ranges from 0 - no anxiety to 21 - severe anxiety.
Time Frame
4 weeks
Title
Change in depression symptoms using PHQ-9
Description
The change in symptoms pertaining to depression will be evaluated using the change in the PHQ-9 score. The PHQ-9 is a general anxiety questionnaire with 9 questions. What does a PHQ-9 score mean? Scores less than 5 often signify the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression; depression scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.
Time Frame
4 weeks
Title
Rate of Adverse Events
Description
Rate and severity of adverse events related to the use of the NeuroGlove assessed by PI during patient interview.
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 anxiety and/or depression.
Suffer from anxiety and/or depression 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.)
The 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Harold
Phone
6122550405
Email
info@neuroglove.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Nussbaum, MD
Organizational Affiliation
NeuroGlove LLC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with researchers outside of the study. Participant data will be deidentified.
Learn more about this trial
NeuroGlove Anxiety and Depression Study
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