Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

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: 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

Treatment and study plan

Vibrotactile Coordinated Reset

Device

The Stanford CR glove is designed to administer vibrotactile coordinated reset stimulation, which consists of vibratory stimulation of the fingertips delivered in a specific pattern which is design to disrupt and normalize abnormal brain synchrony.

Primary outcomes

MDS-UPDRS Part 3

Time frame: Baseline, 6 months, 12 months, 18 months, 24 months

The Movement Disorder Society Unified Parkinsons Disease Rating Scale Part 3 assessment, obtained while the participant is off medication, is a scale that measures motor ability within Parkinsons patients. For part 3, the scales minimum values are 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment.

Study contacts

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

Ellyn Daly

CONTACT

[email protected]

(650) 313-8775

Jessica Yankulova

CONTACT

[email protected]

‭(650) 474-9547‬

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 3, 2024
Registry last updated: Sep 3, 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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