Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study

Stanford University

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Device: Stanford Glove

Study type: Interventional

Funder types: Other

Identifiers

NCT06028477

71954

Details and patient eligibility

About

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms. vCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as Levodopa and/or deep brain stimulation. Patients will be followed for 14 months.

Full description

The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Parkinson's disease and inform the investigators on whether unilateral stimulation could be as effective as bilateral stimulation at producing clinically significant improvements in symptoms.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 92 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Ages 18 or older

• Diagnosed with idiopathic Parkinson's Disease
• Fluent in English
• Off-state UPDRS III motor score at least 30, as assessed within the past 6 months before study consent or at Screening Visit.
• Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form and complete study procedures.

Exclusion criteria

• 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
• Physical limitations unrelated to PD that would affect motor ratings
• Has implantation of a medical device
• Sensory abnormalities of the fingertips

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups

Active stimulation

Active Comparator group

Description:

Participants will receive active stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR

Treatment:

Device: Stanford Glove

Sham Stimulation

Sham Comparator group

Description:

Participants will receive sham stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR

Treatment:

Device: Stanford Glove