NeuroGlove PD Study Clinical
- Conditions
- Parkinson Disease
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NeuroGlove
🇺🇸Minneapolis, Minnesota, United States
NeuroGlove🇺🇸Minneapolis, Minnesota, United States