Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication

Stanford University

Status: Not yet enrolling

Conditions: Parkinson Disease, Idiopathic

Treatments: Device: Vibrotactile Coordinated Reset

Study type: Interventional

Funder types: Other

Identifiers

NCT06583005

75389

Details and patient eligibility

About

The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age at the time of enrollment: Adults 18 and older
• Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
• Fluent in English
• Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
• Lives in the United States

Exclusion criteria

• Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies.
• Any current drug or alcohol abuse.
• Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
• Pregnancy, breast-feeding or wanting to become pregnant.
• Patient is unable to communicate properly with staff (i.e., severe speech problems).
• Excessive drooling

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Stimulation

Experimental group

Description:

Participants will stimulate with the device, called the Stanford CR glove, on a daily or weekly basis depending on their progress through the study procedures. The device itself is a glove that is designed to deliver vibrations to the fingertips of each hand.

Treatment:

Device: Vibrotactile Coordinated Reset