NeuroGlove PD Study Clinical

NCT06578273 | Completed Early Phase 1 FDA Device

• 1 other identifier: REG-1010
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and Feasibility of Peripheral Sensory Stimulation of the Hand in the Treatment of Parkinson's Disease

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Use the UPDRS to Evaluate safety and feasibility of device

  Evaluate safety and feasibility of device use on subjects with active symptoms, monitoring motor symptoms and subjects' sense of well-being. The UPDRS - United Parkinson's Disease Rating scale - developed for research and clinical evaluation will be used. The form has a severity scale with ratings from 0-4 with 0 meaning no severity and 4 meaning extreem severity

  4 weeks

• Use Custom Satisfaction Scale to Rate and severity of adverse events related to the use of the NeuroGlove.

  The Satisfaction scale will assess ease of use, satisfaction, feelings of symptom reduction among other questions with a 5 point scale: Strongly Agree, Agree, Neutral, Disagree, and Strongly Disagree

  4 weeks

Study Arms (1)

single arm

EXPERIMENTAL

Subjects in the study will use NeuroGlove 60 minutes twice per day, 30 minutes to each hand. Subjects will be instructed on coordinating their breathing with device on/off periods to maximize relaxation. Subjects who complete less than 45 minutes of treatment per day will be considered noncompliant and may be replaced.

Device: NeuroGlove

Interventions

NeuroGlove DEVICE

The NeuroGlove is a plastic chamber with multiple apertures along its length to allow for puffs of air to be directed to the volar surface of the distal forearm, the palm, and the fingers. 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. A pneumatic pump delivers intermittent puffs of air cycling between one second on and two seconds off. The hand with the palm facing up is placed within the device chamber on a gel pad to provide a comfortable resting surface for the duration of the treatment, which lasts approximately thirty minutes. The device facilitates the rehabilitation, improvement, or restoration of motion in patients with neurological disorders.

single arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 PD
• Suffer from PD 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.)
• Lacks the ability to comprehend or follow 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

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, homebased, interventional clinical study in which 8 subjects will be enrolled. Eight (8) subjects who suffer from Parkinson's disease will receive treatment using the NeuroGlove.

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 29, 2024
• Study Start: August 22, 2024
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-08

Locations

US (1)