Recruiting

NeuroGlove

Sponsor:

NeuroGlove LLC

Code:

NCT06065787

Conditions

Anxiety

Depression

Anxiety Depression

Depression, Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NeuroGlove

Study Details

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

Study ID

NCT06065787

Start date

Sep 27, 2023

Status verified date

Nov, 2023

Completion date

Nov 1, 2024

Anticipated

Primary completion date

Oct 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NeuroGlove Treatment Arm

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.

Interventions

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.

Primary outcome measure

  • Change in anxiety symptoms using GAD-7 [ Time Frame: 4 weeks ]
  • Change in depression symptoms using PHQ-9 [ Time Frame: 4 weeks ]
  • Rate of Adverse Events [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Thomas Harold

6122550405info@neuroglove.net

Locations

NeuroGlove

Recruiting

Minneapolis, Minnesota, United States, 55416

Contacts

Eric Nussbaum

612-255-0405info@neuroglove.net

More Information

Sponsor

NeuroGlove LLC

Last update posted

Nov 7, 2023

Last verified

Nov, 2023

Keywords

  • Anxiety
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NeuroGlove LLC on 2023-11-07.