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

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stanford Glove
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

35 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Stimulation

    Arm Description

    Patients will be asked to stimulate using a non invasive vibrotactile device.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 1, 2023
    Last Updated
    September 11, 2023
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06029686
    Brief Title
    Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population
    Official Title
    Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stimulation
    Arm Type
    Experimental
    Arm Description
    Patients will be asked to stimulate using a non invasive vibrotactile device.
    Intervention Type
    Device
    Intervention Name(s)
    Stanford Glove
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change in Parkinsonian symptoms as defined by the change in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jessica K Yankulova, MA
    Phone
    6504749547
    Email
    jessky@stanford.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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