NeuroGlove PD Study Clinical

Early Phase 1CompletedNCT06578273

NeuroGlove LLC8 enrolled

Overview

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

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. Up to 8 subjects enrolled and complete study procedures. There will be a single cohort in the study consisting of the subjects with PD who will receive treatment with NeuroGlove.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

NeuroGloveDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject. 2. Men and women ≥18 and \<85 years of age. 3. Carry an active diagnosis of PD 4. Suffer from PD symptoms that impact subject's daily activities and quality of life Exclusion Criteria: 5. Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.) 6. 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. 7. Currently participating in another interventional clinical trial (observational clinical trial participation is allowed for study enrollment.)

Locations (1)

NeuroGlove

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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