NeuroGlove PD Study Clinical

Early Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Device: NeuroGlove

• Registration Number: NCT06578273
• Lead Sponsor: NeuroGlove LLC

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-22
• Primary Completion: 2024-08-22
• Study Completion: 2024-08-22
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	NeuroGlove	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.

Primary Outcome Measures

Name	Time	Method
Use the UPDRS to Evaluate safety and feasibility of device	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
Use Custom Satisfaction Scale to Rate and severity of adverse events related to the use of the NeuroGlove.	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

Trial Locations

Locations (1)

NeuroGlove; 🇺🇸 Minneapolis, Minnesota, United States