Skip to main content
OpenTrials
Completed

NCT Number: NCT06578273

NeuroGlove PD Study Clinical

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

NeuroGlove

Minneapolis, Minnesota, 55416, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 PD
  • Suffer from PD 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.)
  • 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.)

Treatment and study plan

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.

Primary outcomes

  1. Use the UPDRS to Evaluate safety and feasibility of device

    Time frame: 4 weeks

    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

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

    Time frame: 4 weeks

    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

Sponsors and collaborators

Lead sponsor

NeuroGlove LLC

Industry

Registry information

Official study title

Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Parkinson's Disease: Assessing Safety and Feasibility

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.