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

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ClinicalTrials.gov Identifier: NCT06029686
Recruitment Status : Not yet recruiting
First Posted : September 8, 2023
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Peter Tass, MD, PhD, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Stanford Glove Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Stimulation
Patients will be asked to stimulate using a non invasive vibrotactile device.
 Device: Stanford Glove
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   35 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at the time of enrollment: 35 - 92 years
  2. Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to
  3. Fluent in English
  4. 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.
  5. Feels comfortable going off PD related medication during in person study visits
  6. Lives in the United States

Exclusion Criteria:

  1. Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
  2. Any current drug or alcohol abuse.
  3. 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.
  4. Pregnancy, breast-feeding or wanting to become pregnant
  5. Craniotomy
  6. Brain surgery
  7. Patient is unable to communicate properly with staff (i.e., severe speech problems)
  8. Excessive drooling
  9. Patient is taking a medication that may cause significant withdrawal effects
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06029686


Contacts
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Contact: Jessica K Yankulova, MA 6504749547 jessky@stanford.edu

Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Peter A Tass, MD, PhD Stanford University
More Information
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Responsible Party: Peter Tass, MD, PhD, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT06029686    
Other Study ID Numbers: 71725
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases