An Early Phase 1 interventional study of NeuroGlove in Parkinson Disease, sponsored by NeuroGlove LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by NeuroGlove LLC · Early Phase 1, Interventional, and Device feasibility
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →NeuroGlove LLC is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: NeuroGlove
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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NeuroGlove LLC