Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stanford Glove.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 18 years — 92 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score [Time frame: Baseline and month 6]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT06028477 · 71954