NeuroGlove Anxiety and Depression Study

NCT ID: NCT06065787

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-27

Study Completion Date

2024-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Depression Anxiety Depression Depression, Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

NeuroGlove

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NeuroGlove LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eric Nussbaum, MD

Role: PRINCIPAL_INVESTIGATOR

NeuroGlove LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NeuroGlove

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thomas Harold

Role: CONTACT

6122550405

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eric Nussbaum

Role: primary

612-255-0405

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REG-1006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurofeedback Training for PD
NCT05987865 NOT_YET_RECRUITING NA