NeuroGlove Anxiety and Depression Study

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065787
• Other study ID #: REG-1006
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2023
• Source: NeuroGlove LLC
• Contact: Thomas Harold
• Phone: 6122550405
• Email: info[@]neuroglove.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 1, 2024
• Est. primary completion date: October 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 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.)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Depression
• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder

Intervention

Device:
• NeuroGlove
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.

Locations

Country	Name	City	State
United States	NeuroGlove	Minneapolis	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	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.	4 weeks
Primary	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.	4 weeks
Primary	Rate of Adverse Events	Rate and severity of adverse events related to the use of the NeuroGlove assessed by PI during patient interview.	4 weeks