NeuroGlove Anxiety and Depression Study

Not Applicable

Recruiting

• Conditions: Anxiety; Depression, Anxiety; Depression; Anxiety Depression
• Interventions: Device: NeuroGlove

• Registration Number: NCT06065787
• Lead Sponsor: NeuroGlove LLC

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.

Study Timeline

• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-26
• Study Start: 2023-09-27
• Study First Posted: 2023-10-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-10-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeuroGlove Treatment Arm	NeuroGlove	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.

Primary Outcome Measures

Name	Time	Method
Change in depression symptoms using PHQ-9	4 weeks	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	4 weeks	Rate and severity of adverse events related to the use of the NeuroGlove assessed by PI during patient interview.
Change in anxiety symptoms using GAD-7	4 weeks	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.

Trial Locations

Locations (1)

NeuroGlove; 🇺🇸 Minneapolis, Minnesota, United States