NCT06578273

NeuroGlove PD Study Clinical

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: NeuroGlove LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-22
• Primary completion: 2024-08-22
• Completion: 2024-08-22
• First posted: 2024-08-29
• Last updated: 2024-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study