Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms of a more variable population. 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 two years.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

35 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age at the time of enrollment: 35 - 92 years
Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to
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.
Feels comfortable going off PD related medication during in person study visits
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
Craniotomy
Brain surgery
Patient is unable to communicate properly with staff (i.e., severe speech problems)
Excessive drooling
Patient is taking a medication that may cause significant withdrawal effects

Treatment and study plan

Stanford Glove

Device

The vibrotactile device sends weak non-painful pattern type vibratory stimulus to the fingertips and is non-invasive. Some patient may experience dyskinesia which can me medicated with a decrease in Parkinson's medication

Primary outcomes

Change in Parkinsonian symptoms as defined by the change in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score

Time frame: 6 months

Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score.

Minimum score - 0 indicates normal functioning Maximum score - 132 indicated severe impairment

Lower scores indicate greater functionality and higher scores indicate severe impairment in functionality.

Study contacts

Contact information is provided by the study sponsor or research team.

Ellyn Daly

CONTACT

[email protected]

6509450174

Jessica K Yankulova, MA

CONTACT

[email protected]

6504749547

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Sep 8, 2023
Registry last updated: Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Not yet recruiting