NeuroGlove Anxiety and Depression Study

NCT06065787 | Unknown FDA Device

• 1 other identifier: REG-1006
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Anxiety Depression; Depression, Anxiety

Keywords

Anxiety; Depression

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

NeuroGlove Treatment Arm

EXPERIMENTAL

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

Interventions

NeuroGlove DEVICE

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.

NeuroGlove Treatment Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• NeuroGlove LLC: lead

Study Sites (1)

NeuroGlove

Minneapolis, Minnesota, 55416, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Eric Nussbaum, MD

  NeuroGlove LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Harold

CONTACT

6122550405; info@neuroglove.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 4, 2023
• Study Start: September 27, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)