Parkinson Disease
Conditions
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.
Interventions
DEVICENeuroGlove
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.
Sponsors
NeuroGlove LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed