An interventional study of NeuroGlove in Anxiety, Depression and Anxiety Depression, sponsored by NeuroGlove LLC. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by NeuroGlove LLC · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 10 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →NeuroGlove LLC is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
Rate of Adverse Events
Rate and severity of adverse events related to the use of the NeuroGlove assessed by PI during patient interview.
Time frame: 4 weeks
Plan to share: No — Individual participant data will not be shared with researchers outside of the study. Participant data will be deidentified.
No publications or documents are linked to this record.
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