NCT06028477

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 92 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Stanford Glove	The non-invasive neuromodulation hardware system comprises two wireless controllers/battery packs which are fastened to the top of each hand via an adjustable elastic strap. Each controller is equipped with four vibrotactile fingertip stimulators, also known as tappers. There is a total of eight tappers (for index, middle, ring and pinkie of each hand) per system.

Timeline

• Start date: 2025-01-10
• Primary completion: 2026-12-30
• Completion: 2027-03-01
• First posted: 2023-09-08
• Last updated: 2024-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study