NeuroGlove PD Study Clinical

NeuroGlove

Status and phase: Completed; Early Phase 1

Conditions: Parkinson Disease

Treatments: Device: NeuroGlove

Study type: Interventional

Funder types: Industry

Identifiers

NCT06578273

REG-1010

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

single arm

Experimental group

Description:

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.

Treatment:

Device: NeuroGlove