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
Verified date | November 2023 |
Source | NeuroGlove LLC |
Contact | Thomas Harold |
Phone | 6122550405 |
info[@]neuroglove.net | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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.) |
Country | Name | City | State |
---|---|---|---|
United States | NeuroGlove | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
NeuroGlove LLC |
United States,
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 |
Status | Clinical Trial | Phase | |
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